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Clinical Research Coordinator Roles and Responsibilities

Position Role Sponsored Program Administration Financial Management Effort Reporting Conflicts of Interest Human Research Participant Protection Environmental Health and Safety Human Gene Transfer Export Controls

Position Role

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

The clinical research coordinator reports primarily to the Principal Investigator with associated responsibilities to the department head, division administrator or program administrator.

Preparation of Scientific Proposal

Assists the PI in study feasibility assessments as requested.

Proposal Budget

Collaborates with the PI and department to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.

Protocol Preparation & Review

Reviews and comprehends the protocol.
Attends investigator meetings as required or requested by the PI.
Collaborates with the PI to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol.
Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.

Award Acceptance (Terms & Conditions)

Reviews and develops a familiarity with the contract or award terms and conditions. Works with the PI to assure that the study is in compliance with all terms and conditions, including but not limited to education, IRB (HRPO) approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.

Conduct of Research

Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
Works with the PI to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.
Conducts or participates in the informed consent process including interactions with the HRPO (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
Registers participants to the appropriate coordinating center (if multi-site study).
Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
Coordinates participant tests and procedures.
Collects data as required by the protocol. Assures timely completion of Case Report Forms.
Maintains study timelines.
Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Washington University Policy on Investigational Drug/Device Accountability.
Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
Retains all study records in accordance with sponsor requirements and university policies and procedures.
Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
Assists PI in preparation of any modifications to the scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures.
Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Washington University’s Research Integrity Policy and other misconduct as described in Washington University’s Code of Conduct.
Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures. Assists in the registration (if required) of the study at ClinicalTrials.gov and maintains current information on the site.

Project Closeout

Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable federal agencies, university entities, and the sponsoring agency in accordance with federal regulations and university and sponsoring agency policies and procedures.
Arranges secure storage of study documents that will be maintained according to university policy or for the contracted length of time, whichever is longer.

Financial Management

Reviews and accepts/corrects the billing matrix as set up by the Center for Applied Research Science (CARS) to facilitate billing of study procedures to the appropriate research fund.
Coordinates appropriate and timely payments to participants (if applicable) in accordance with university policies and procedures.

Effort Reporting

Reviews, adjusts and legally certifies personnel activity reports if applicable. Completes effort reporting certification within the timeframe specified by Sponsored Project Accounting.

Conflicts of Interest

Takes appropriate steps to avoid conflicts of interest, or the appearance of conflicts of interest, between financial or other personal interests and the goals and policies of the university.
Complies with applicable school, university, and sponsoring agency conflict of interest policies and procedures. Discloses all financial conflicts of interest to the appropriate supervisor.
Cooperates with university compliance and monitoring efforts related to conflicts of interest and reports instances of noncompliance to the appropriate compliance office.

Human Research Participant Protection

Assists Principal Investigator in protection of the rights and welfare of all human research participants involved in research in accordance with federal regulations and university and sponsoring agency policies and procedures.
Assists Principal Investigator in assuring that all key personnel involved in human research have completed the required education for the protection of human research participants in accordance with federal regulations and university and sponsoring agency policies and procedures. Maintains proof of all such education for all engaged members of the study team. Coordinates with Principal Investigator and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with Federal regulations and University and sponsoring agency policies and procedures.
Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
Cooperates with university compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and/or sponsors.
Collaborates with PI and institution to respond to any audit findings and implement approved recommendations. Cooperates with university and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
Collaborates with the PI to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested by the PI. These study materials include but are not limited to the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
Establishes and organizes study files, including but not limited to, regulatory binders, case report forms, study specific source documentation.

Informed Consent

Assists in preparation of all documents related to the informed consent process.
Assists Principal Investigator in preparation and submission of informed consent documents to HRPO for review and approval.
Collects documents needed to initiate the study for submission to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
Conducts or participates in the informed consent process including interactions with the HRPO (IRB), discussions with research participants, including answering any questions related to the protocol. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
Collects data as required by the protocol. Assures timely completion of Case Report Forms.
Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc.
Retains all study records in accordance with sponsor requirements and University policies and procedures.
Assists PI in preparation and submission of any modifications to the scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures.

Protected Health Information

Adheres to and supports all Federal regulations and University policies and procedures instituted to safeguard protected health information (PHI).
Completes the appropriate level of training regarding the access, use, and disclosure of PHI in accordance with Federal regulations and University and sponsoring agency policies and procedures. Assists PI to assure that all personnel complete appropriate training.
Cooperates with University compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.

Unanticipated Problems

Assists the Principal Investigator in promptly reporting any unanticipated problems involving risks to research participants or others to the HRPO (Washington University’s IRB).
Assists Principal Investigator with scientific and compliance reporting requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
Assists in the registration (if required) of the study at ClinicalTrials.gov and maintains current information on the site.
Arranges secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer.

Environmental Health and Safety

Assists Principal Investigator in assuring that individuals handling hazardous or regulated materials are well trained in proper safety procedures and have completed required environmental health and safety training in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
Works with Environmental Health and Safety to ensure that all facilities used are in compliance with all applicable regulations. Maintains copies of any applicable facility audits and equipment inspection/service reports.

Human Gene Transfer

Assists Principal Investigator in assuring that all key personnel involved in human research have completed the required education for the protection of human research participants in accordance with Federal regulations and University and sponsoring agency policies and procedures. Maintains proof of all such education for all engaged members of the study team. Coordinates with Principal Investigator and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with Federal regulations and University and sponsoring agency policies and procedures.
Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
Cooperates with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and/or sponsors.
Cooperates with University and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
Collaborates with the PI to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested by the PI. These study materials include but are not limited to the informed consent documents, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
Engages participants in the informed consent process according to the HRPO approved process.

Award Acceptance (Terms & Conditions)

Reviews and develops a familiarity with the contract or award terms and conditions. Works with the PI to assure that the study is in compliance with all terms and conditions, including but not limited to education, IRB (HRPO) approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.
Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor and/or Washington University Policy on Investigational Drug/Device Accountability.
Completes study documentation and maintains study files in accordance with sponsor requirements and university policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc.
Adheres to and supports all federal regulations and university policies and procedures instituted to safeguard protected health information (PHI).
Completes the appropriate level of training regarding the access, use, and disclosure of PHI in accordance with federal regulations and university and sponsoring agency policies and procedures. Assists PI to assure that all personnel complete appropriate training.
Cooperates with university compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.
Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures.

Export Controls

Develops awareness of export control regulations and complies as appropriate.

Revised January 2009 | Created 2007

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The Role of a Clinical Research Coordinator

Clinical research plays a crucial role in advancing medical knowledge and improving patient care. At the heart of every successful clinical research study is a Clinical Research Coordinator (CRC). As a CRC, you serve as the linchpin between researchers, study participants, and regulatory bodies.

In this comprehensive guide, we will explore the responsibilities, qualifications, challenges, and rewards of being a Clinical Research Coordinator. Whether you are considering a career in clinical research or already working in the field, this article provides valuable insights to help you succeed.

Responsibilities of a Clinical Research Coordinator

As a Clinical Research Coordinator, your responsibilities are diverse and demanding. You serve as the primary point of contact for study participants, ensuring their safety and well-being throughout the research process. You are responsible for recruiting and enrolling eligible participants, obtaining informed consent, and collecting accurate data. Additionally, you must adhere to strict regulatory guidelines and Good Clinical Practice ( GCP ) standards to ensure the integrity and validity of the study results.

Monitoring participants' progress, managing adverse events, and maintaining detailed records are also crucial aspects of your role as a CRC. To effectively carry out these responsibilities, strong organizational and communication skills are essential. You must be able to multitask, prioritize, and work well under pressure. Attention to detail is paramount, as any errors or oversights can compromise the validity of the study. As a CRC, you are also expected to stay updated on the latest research protocols and regulatory requirements to ensure compliance and contribute to the successful completion of the study.

Qualifications and Education Required to Become a Clinical Research Coordinator

While specific qualifications may vary depending on the institution or organization, a minimum educational requirement for most Clinical Research Coordinator positions is a bachelor's degree in a relevant field such as life sciences, nursing, or pharmacy. A solid foundation in biological sciences and research methodologies is crucial to understanding the complexities of clinical research. A master's degree in clinical research or a related field can further enhance your qualifications and open up opportunities for career advancement.

Apart from formal education, relevant work experience is highly valued in the field of clinical research. Prior experience in a research setting, such as working as a research assistant or in a healthcare role, can provide valuable insight into the research process and make you a more competitive candidate. Additionally, possessing knowledge of regulatory guidelines, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH-GCP ) guidelines, is advantageous.

Certification Options for Clinical Research Coordinators

While certification is not always mandatory, obtaining a certification as a Clinical Research Coordinator can enhance your professional credibility and increase your job prospects. Several organizations offer certification programs for CRCs, such as the Association of Clinical Research Professionals ( ACRP ) and the Society of Clinical Research Associates ( SoCRA ). To obtain certification, you typically need to meet certain eligibility criteria, which may include a combination of education, work experience, and passing a certification exam.

These certification programs cover a wide range of topics, including research ethics, study design, data management, and regulatory compliance. By obtaining certification, you demonstrate your commitment to maintaining high standards of practice and staying up-to-date with industry best practices.

Tips for Creating an Effective Clinical Research Coordinator Resume

In a competitive job market, a well-crafted resume can make all the difference in securing a Clinical Research Coordinator position. Here are some tips to help you create an effective resume that highlights your skills and qualifications:

1. Start with a compelling summary: Begin your resume with a concise summary that highlights your relevant experience, qualifications, and career goals. This section should grab the attention of potential employers and encourage them to read further.

2. Emphasize your research experience: Highlight your research experience, including any previous roles as a research assistant or involvement in clinical trials. Describe your responsibilities, methodologies used, and any noteworthy achievements.

3. Showcase your knowledge of regulations and guidelines: Demonstrate your familiarity with regulatory guidelines, such as ICH-GCP, and any additional certifications you have obtained. This shows your commitment to ethical research practices and compliance.

4. Highlight your organizational and communication skills: As a CRC, strong organizational and communication skills are crucial. Provide examples of how you have effectively managed multiple tasks, coordinated with various stakeholders, and maintained accurate documentation.

5. Include relevant technical skills: Depending on the specific requirements of the position, include any relevant technical skills such as proficiency in electronic data capture systems, statistical software, or data analysis tools. These skills can set you apart from other candidates.

Remember to tailor your resume to each specific job application, focusing on the skills and qualifications that are most relevant to the position. Proofread your resume carefully to ensure it is error-free and presents you in the best possible light.

Common Interview Questions for Clinical Research Coordinator Positions

Preparing for a job interview is essential to present yourself confidently and effectively. Here are some common interview questions for Clinical Research Coordinator positions, along with tips on how to answer them:

1. Tell us about your experience in clinical research: Be prepared to discuss your previous roles and responsibilities in clinical research, emphasizing your ability to manage study participants, collect accurate data, and ensure compliance with regulatory guidelines.

2. How do you handle challenges in clinical research?: Demonstrate your problem-solving skills by sharing examples of challenging situations you have encountered and how you successfully resolved them. Emphasize your ability to adapt to unexpected circumstances and maintain a high level of professionalism.

3. How do you ensure participant safety and informed consent?: Highlight your understanding of the importance of participant safety and informed consent in clinical research. Explain your approach to obtaining and documenting informed consent, as well as your strategies for monitoring participant well-being.

4. How do you manage time and prioritize tasks?: Showcase your organizational and time management skills by describing how you handle multiple tasks, prioritize responsibilities, and meet deadlines. Provide examples of how you have effectively managed your workload in previous roles.

5. What are your strategies for maintaining accurate and detailed documentation?: Stress the importance of accurate documentation in clinical research and describe your methods for ensuring meticulous record-keeping. Discuss your attention to detail and your ability to maintain confidentiality.

Remember to practice your responses to these questions beforehand, focusing on providing concise and well-thought-out answers. Also, prepare questions to ask the interviewer to demonstrate your interest in the role and organization.

Challenges and Rewards of Being a Clinical Research Coordinator

Working as a Clinical Research Coordinator comes with its own set of challenges and rewards. It is essential to be aware of both aspects to make an informed decision about pursuing a career in this field.

Challenges:

1. Time management: Balancing multiple tasks and deadlines can be challenging, especially when working on multiple studies simultaneously. Strong organizational skills and the ability to prioritize effectively are crucial.

2. Regulatory compliance: Adhering to strict regulatory guidelines and ensuring compliance with ethical standards can be complex. Staying updated on the latest regulations and guidelines is essential to avoid any non-compliance issues.

3. Participant recruitment: Recruiting and enrolling eligible participants can be challenging, particularly when dealing with specific inclusion and exclusion criteria. A proactive and strategic approach to participant recruitment is necessary.

Rewards:

1. Contribution to medical advancements: As a Clinical Research Coordinator, you play a vital role in advancing medical knowledge and improving patient care. The data and insights you collect contribute to the development of new treatments and therapies.

2. Personal and professional growth: Working in clinical research provides continuous opportunities for learning and professional development. You gain valuable experience in research methodologies, data management, and regulatory compliance.

3. Making a difference: By ensuring participant safety and well-being, you make a meaningful impact on the lives of study participants. Clinical research coordinators are instrumental in bringing new treatments and therapies to patients in need.

The challenges and rewards of being a Clinical Research Coordinator often go hand in hand. The satisfaction of overcoming challenges and contributing to medical advancements can be immensely rewarding and fulfilling.

Continuing Education and Professional Development Opportunities

Continuing education and professional development are crucial for Clinical Research Coordinators to stay updated on the latest research methodologies, regulations, and best practices. Here are some opportunities for ongoing learning and growth:

1. Workshops and conferences: Attend workshops and conferences related to clinical research to expand your knowledge, network with industry professionals, and stay informed about the latest advancements in the field.

2. Online courses and webinars: Take advantage of online courses and webinars offered by reputable organizations and institutions. These courses cover a wide range of topics, from research ethics to data analysis.

3. Association membership: Join professional associations such as the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates ( SoCRA ). These associations offer resources, networking opportunities, and certification programs.

4. Advanced degrees: Consider pursuing an advanced degree, such as a master's or doctoral degree, in clinical research or a related field. This can provide in-depth knowledge and open up opportunities for leadership roles in the field.

Continuing education not only enhances your skills and knowledge but also demonstrates your commitment to professional growth and maintaining high standards of practice.

Resources and Associations

As a Clinical Research Coordinator, it is essential to stay connected with the wider clinical research community and have access to valuable resources. Here are some notable associations and resources for CRCs:

1. Association of Clinical Research Professionals ( ACRP ): ACRP is a global membership association that provides educational resources, networking opportunities, and certification programs for clinical research professionals.

2. Society of Clinical Research Associates ( SoCRA ): SoCRA offers certification programs, training resources, and networking opportunities for clinical research professionals. They also publish a quarterly journal, "The Monitor," which provides valuable insights and updates in the field.

3. ClinicalTrials.gov : ClinicalTrials.gov is a public database maintained by the U.S. National Library of Medicine. It provides information on clinical trials worldwide, allowing CRCs to stay updated on ongoing and upcoming studies.

4. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH ): The ICH website provides access to guidelines and standards for the conduct of clinical research. Familiarize yourself with these guidelines to ensure compliance and ethical conduct.

By utilizing these resources and actively engaging with professional associations, you can stay informed about the latest industry developments, connect with peers, and access valuable tools and support.

The role of a Clinical Research Coordinator is diverse, demanding, and rewarding. As a CRC, you play a crucial role in advancing medical knowledge, ensuring participant safety, and contributing to the development of new treatments and therapies. By understanding the responsibilities, qualifications, and challenges of the role, you can position yourself for success in the field of clinical research.

Continuously seek opportunities for professional growth, stay updated on the latest regulations and best practices, and actively engage with the clinical research community. With dedication, passion, and a commitment to excellence, you can thrive as a Clinical Research Coordinator and make a significant impact in the field of clinical research.

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Clinical research coordinator work environment

We surveyed 2,472 clinical research coordinators to better understand the work environment and required skills of a typical clinical research coordinator. Here are the results.

How much intelligence is required as a clinical research coordinator?

Working as a clinical research coordinator typically requires higher levels of intelligence when compared with the average career. This means that clinical research coordinators are required to actively learn new things related to their discipline and solve complex problems.

Can I learn to become a clinical research coordinator?

Intrinsic talent, acquired talent.

A career as a clinical research coordinator typically depends predominantly on qualities you can gain through experience, with a small aspect of skills you are born with.

Is it easy to get a job as a clinical research coordinator?

It’s typically difficult to find a job as a clinical research coordinator. If you’re curious about the numbers, check out the job market for clinical research coordinators .

Do clinical research coordinators work full-time or part-time?

80% of clinical research coordinators work in full-time roles while 20% work part-time.

Is being a clinical research coordinator stressful?

Clinical research coordinators tend not to find their jobs stressful, which likely contributes positively to career satisfaction.

Is being organized important as a clinical research coordinator?

Organization is considered a very important trait for clinical research coordinators, and is critical to success in the field.

How competitive is the workplace for clinical research coordinators?

Competition at work is not common for clinical research coordinators.

Does being a clinical research coordinator require frequent time pressure to complete tasks?

Time pressure tends not to be a major contributor of stress for clinical research coordinators.

Are clinical research coordinators allowed to express themselves creatively?

Clinical research coordinators rarely get a chance to express themselves creatively.

Do clinical research coordinators have control over the direction of their work?

Clinical research coordinators tend to have a set and inflexible work schedule that they are unable to deviate from too much.

Is being a clinical research coordinator physically demanding?

Work as a clinical research coordinators is rarely physically demanding, making it a suitable option for those unable to perform physically strenuous tasks.

Are clinical research coordinators exposed to a wide variety of work?

Clinical research coordinators tend to have a monotonous work routine, with little variety in their day-to-day tasks.

Does being a clinical research coordinator require attention to detail?

Attention to detail is a vital skill for clinical research coordinators, as small mistakes can make or break one's ability to succeed in the career.

Does being a good clinical research coordinator require compassion and empathy?

Being compassionate and empathetic is considered helpful to those looking to pursue careers as clinical research coordinators.

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Are you interested in a position that provides career development and growth? How about a position that is multifaceted, rewarding, and where the learning never stops? If so, then Mayo Clinic invites you to consider a life-changing career as a Clinical Research Coordinator. As a Clinical Research Coordinator, you will have the opportunity to work with a variety of people, from patients to care teams, enabling you to be a part of the legacy that puts the needs of the patients first. We have several Clinical Research Coordinator positions available in multiple locations and departments. We have multiple schedules and shifts dependent upon position availability to fit your individual needs. Positions may vary in FTE, from supplemental to full-time. Some positions may also be temporary (less than one year) or limited tenure status (1-2 years in duration) and may have the possibility of turning into a regular position. When you apply, we will take the time to assess your qualifications and preferences to determine which of our current openings would be the best match and ensure your application is reviewed by those active hiring managers. As a Clinical Research Coordinator, you will :

Independently coordinate complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines.
Collaborate with research team to assess feasibility and management of research protocols.
Screen, enroll, and recruit research participants.
Coordinate schedules and monitor research activities and subject participation.
Identify, review, and report adverse events, protocol deviations, and other unanticipated problems appropriately.
Manage, monitor, and report research data to maintain quality and compliance.
Provide education/training for others within the department.
Perform administrative and regulatory duties related to the study as appropriate.
Participate in other protocol development activities and other assignments as assigned.
Actively partner with team members by fostering an inclusive work environment and respecting others with different backgrounds, experiences and perspectives.

**This position will require candidates to work on campus, and live within driving distance of the campus. To learn more about Research at Mayo Clinic, visit our website here . **During the selection process you will participate in an OnDemand (pre-recorded) interview that you can complete at your convenience. During the OnDemand interview, a question will appear on your screen, and you will have time to consider each question before responding. You will have the opportunity to re-record your answer to each question – Mayo Clinic will only see the final recording. The complete interview will be reviewed by a Mayo Clinic staff member and you will be notified of next steps.**

Must meet one of the following:

HS Diploma with at least 5 years of clinical research coordination/related experience OR
Associate's degree/college Diploma/Certificate Program with at least 3 years of experience, Associate's in Clinical Research from an accredited academic institution without experience OR
Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience.
Experience should be in the clinical setting or related experience.

Additional Qualifications

Graduate or diploma from a study coordinator training program is preferred.
One year of clinical research experience is preferred.
Medical terminology course is preferred.

*Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension.

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Ccrc® (certified clinical research coordinator) is a credential formally recognizing clinical research professionals with experience coordinating and facilitating clinical trial activities in adherence to gcp, under the direction of a principal investigator., this trusted mark of excellence in clinical research is awarded to clinical researchers who have demonstrated proficiency of specific knowledge and skills by passing the standardized ccrc® certification exam..

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Contemp Clin Trials Commun
v.32; 2023 Apr

Clinical research coordinators: Key components of an efficient clinical trial unit

Vincenzina mora.

a Unità Coordinamento Trials (UCT) 2, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico A. Gemelli, IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy

Stefania Colantuono

Caterina fanali, alessia leonetti, giulia wlderk, maria antonia pirro, francesca maria calà palmarino, roberta savini, gianluca ianiro.

b CEMAD Digestive Disease Center, Fondazione Policlinico Universitario A. Gemelli IRCCS, Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy

Antonio Gasbarrini

Multicenter trials involve procedures, rules, and guidelines that require meticulous attention to details and strict adherence to compliance issues. It is widely accepted that the design, implementation, coordination and analysis of modern clinical trials require a multidisciplinary specialist approach [ 1 ]. At the same time, appropriate training and mastery of the competencies that characterize each role of the research process are essential to carry out high-quality clinical and translational research [ 2 , 3 ]. Usually research teams include the principal investigator (PI), sub-investigators (SI), clinical study nurses (CSNs), clinical research coordinators (CRC), also called study coordinators (SC) and other figure as data manager, statisticians, and clinical monitors also called clinical research associates (CRAs).

Although study coordinator figure exists for at least two decades, the CRCs position and their key role in the scenario of clinical trials, have only recently been defined [ [4] , [5] , [6] , [7] ]. While the responsibilities of investigators, sponsors and clinical monitors are well defined by national regulations of clinical trials and international guidelines on Good Clinical Practice, the importance of the CRC position, their responsibilities and main tasks, have not yet been completely described. Moreover, there is limited available evidence on this topic, since most papers mainly address the required skills of a CRC or describe their responsibilities within a specific topic. Moreover, the term data manager and study coordinator have often been used as synonyms for many years and this may have contributed to confusion and delay in CRC precise definition.

Data for this review were identified by searches of MEDLINE, Current Contents, PubMed, and references from relevant articles, using the search terms “clinical research coordinator”, “study coordinator”, “research nurse”. Other search engines, as Google Scholar, have been considered in a second review of scientific literature, despite its limitations [ 8 ]. All found papers have been critically evaluated for review. Only article published in English were included; English abstract of other languages papers have been excluded from review when not sufficient to fully describe the study design.

The definition provided by the Association of Clinical Research Professionals states that " A Clinical Research coordinator, Study Site Research Nurse or Study Site Coordinator, works at a clinical research site under the immediate direction of a principal investigator, whose research activities are conducted under Good Clinical Practice regulations. Among other tasks, CRC's perform site preparation, patient screening and recruitment, patient enrolment, conduct and ensure the quality of case report forms, maintain source documents, and ensure site quality" [ 9 ].

This definition clearly separates the roles of CRCs and CSNs from those of data managers, whose activities represent only a part of the multiple tasks that belong to CRCs and nurses, as further described below and summarized in Table 1 .

CRC activities, divided in different areas, modified from Rico-Villademoros F et al. 2004 .

Even though recent literature has focused on the importance of these positions, the figure of CRCs is still likely to be neglected and undervalued in research practice. Moreover, it is possible to find an overlap of the professional figures, because many sites do not have the possibility to hire all the staff necessary to support the research. Therefore, it is frequent to find sub-inv and/or SN that fulfill the role and responsibilities of CRC and this may generate confusion between different roles.

In 2002 a group of American authors referred to CRCs as the invisible hand in clinical research [ 10 ]. They underlined that the CRCs are crucial for the success of clinical research due to their wide range of responsibilities, representing the connection between study sponsor and patients and clinical, regulatory and administrative staff. CRCs’ central position is highlighted in Fig. 1 that shows their specific coordinating role.

Figure shows the central position of CRC and the connections with all the subjects involved in the research machine .

In 2004, a Spanish group performed a survey to elucidate the standard tasks performed by CRCs in oncology clinical trials, to assess their job satisfaction and training needs [ 11 ]. They found some inaccuracies, starting from the definition of their role. More than two-thirds of the respondents were called "Data Managers'' while the title "Clinical Research Coordinator" (i.e. titles that included both terms "research" and "coordinator") appeared in only 3 job titles. As for educational level and training, they generally had a university degree (Medicine, Pharmacy, Biology and Nursing as the most frequent) and received specific training (Oncology, Clinical Research, Clinical Trials, GCP, Statistics, Database preparation & management in the majority of cases). As for the tasks, overall, CRCs seemed to be devoted to what we call "monitoring activities'', including patient registration/randomization, recruitment follow-up, case report form (CRF) completion, collaboration with the CRA, serious adverse events (SAE) reporting, investigator file handling, and preparing the site for and/or attending audits. It was not uncommon for CRCs participating in that survey to deal with the hospital pharmacy. They maintained the required records of study activity, including drug accountability logs, regulatory documents as well as financial records. To a lesser extent, they were also involved in some administrative activities (such as Ethic committee submission and scheduling patient's visits), and various clinical activities (inclusion/exclusion criteria assessment and completion of scales/questionnaires) ( Table 1 ). The CRC ensures that clinical trials run smoothly and preserve data quality, monitors study activity to guarantee protocol compliance and all relevant local, federal, and national regulatory and institutional policies. Although the PI is responsible for the overall conduct of the clinical trial, the CRC is responsible for the daily activities.

CRCs collaborate with the study nurse, but while the role of the clinical study nurse has been defined better during past years, CRCs’ role is still vague. The study nurse is essential in the management of everything related to research participants. The CRC is crucial in the management and coordination of the entire study protocol, from the early stages of the site selection to the close out visit.

Already many years ago, the addition of research nurses to clinical studies was found to have a positive effect on patient enrollment [ 12 ], showing that without a stable, knowledgeable research nurse workforce, the conduction of research is significantly affected. To address the need for educating clinical research nurses to support clinical trials, dedicated training programs were proposed [ 13 ], as the engagement of well-trained and motivated nurses in clinical trials is known to improve patient outcomes [ 14 ].

If the involvement of CSN in clinical trials is a crucial factor, studies have shown that adding a coordinator to a research team significantly improves subject recruitment numbers, subject retention and general study efficiency [ 11 ], increasing general quality in all study phases. A more active involvement of CRCs in the activities of clinical trials, including a more frequent participation to investigators meetings and a deeper contribution in protocol/case report form review and design, is advocated, since the CRC can provide a worthy perspective on the logistics of proposed study procedures. Finally, the involvement of CRCs in such activities will have a positive influence on their job satisfaction. A recent Italian survey, proposed by AIOM CRC Working Group and involving 319 oncology sites [ 15 ], confirmed a direct association between the number of clinical studies and the number of coordinators, whose contribution to the research activities was believed to be essential for trial conduction. More than 80% of participating sites associated the improvement of the quality of clinical research to the implementation of a coordinator as member of the team.

In 2018 a Japanese group examined the present status and the perspectives toward broader contribution of clinical research coordinators by a cross-sectional study [ 16 ]. More than 70% of the respondents were affiliated with medical institutions but were mainly involved in industry-initiated registration trials, mainly for funding issues. Half of the CRCs and other clinical research-related personnel viewed a broadening of CRCs’ involvement in research activities positively. Accordingly, a structured practical program aimed at encouraging such involvement may help expanding and strengthening their contribution into the future. Additionally, it is plausible that a greater involvement of CRCs in clinical research will help to ensure the reliability of investigator-initiated clinical research.

With the increase in regulatory oversight among clinical trials and upcoming novelties in regulatory procedures, the demands and expectations of CRCs have increased and therefore now require additional skills, training, and medical knowledge ( Table 2 ). Even if the role is often considered as administrative, CRCs have, as mentioned above, university education and are highly qualified. However, CRC is still considered a transient position, probably for the lack of professional identity for these roles, leading to unclear training requirements and job criteria.

Table summarizes the most important requested skills for a CRC.

In Italy in particular, the CRC professional profile is not formally recognized by specific certifications, and no formal CRC position exists in institutions’ staff, as required by national health care workforce regulations. This makes it difficult for institutions and policy makers to appraise the demand for CRCs and to respond by allocating the necessary resources [ 17 ].

Competency based training is critical to the task demands of CRCs. Nonetheless, staff turnover is high and opportunities for advancement limited, particularly at academic health centers. Although hiring a CRC represents a significant investment in time and training to properly carry out job responsibilities, turnover in this role is as much costly, mainly due to the time for education and development, marketing and recruitment, loss of productivity during orientation and training, and emotional costs of turnover on current staff. From this point of view, it is advantageous to retain individuals in this position for extended periods, positioning this role as a long-term career [ 18 , 19 ]. A recent paper by Buchanan DA and colleagues [ 20 ] focused on factors associated with job satisfaction and increased retention. These authors found that, although salary and compensation were a significant predictor of retention among this select population of clinical research staff, greater predictors of retention were related to the involvement and relationship with the PI, showing the importance to invest time in building genuine relationships with study staff.

The lack of a well-defined job position and scarce compensation on one hand, and the work overload generated by the continuous updating of regulatory procedures, without structured training and educational programs on the other, are probably the major causes of frustration and dissatisfaction reported from CRCs. In this point of view, some emerging evidences [ 21 ] indicated that the burnout phenomenon, that has been extensively investigated among health care professionals, particularly on physicians and nurses, does not even spare CRCs. Resilience, sleep dysfunction, stress, and incivility experienced from patients/family have been found significant predictors of burnout for oncology CRCs in a recent mixed-method American study [ 22 ].

1. Conclusion

Our review underlines that, being still not well defined, some crucial research roles as CRCs and study nurses are as heterogeneous as their tasks and job positions in different research contexts. As data management activities represent only a very small part of the multiple tasks usually performed by study coordinators, the term Clinical Research Coordinator is certainly more appropriate.

Emerging evidence [ 11 , 15 , 17 , 18 ] confirms that the establishment of a clear job description, the involvement as central positions in the complex research machine, and the standardization and regulation of their job titles are essential to avoid CRCs migration towards the private sector and guarantee academic successful and high-standard quality research.

No specific grant from any funding agency in the public, commercial, or not-for-profit sectors was received for this manuscript.

Author statement

All authors contributed to the concept of the manuscript. VM and SC conceptualized the idea, elaborated draft and revised versions of the manuscript. GW, MAP, RS and FMCP collaborated in bibliographic research and revised it critically, CF and AL edited and revised the manuscript and collaborated to built tables and figure, GI and AG coordinated and integrated work, providing their intellectual contribute to the manuscript. All authors approved this version to be published.

Declaration of competing interest

All authors declare no conflict of interest.

Acknowledgements

A special mention to Dr. D. Piacentini and Dr. R. Galluzzi (Direzione Risorse Umane, Fondazione Policlinico Universitario A. Gemelli, IRCCS) to contribute to define research profiles and job description within Fondazione and to Fondazione Roma (Via del Corso 239, 00187, Rome) for the relevant and continuous support to CEMAD in clinical research and its applications.

Contributor Information

SC&RN group 2 : Pirozzoli Maria Celeste , Giannone Luciana , Spataro Cristina , Graziani Cristina , Capodrossi Anna , Teberino Maria Anna , Tolusso Barbara , Di Ciurcio Marica , Verdirosi Diana , Rotunno Serena , Finotti Ludovica , Turchini Laura , Amatucci Valeria , Schiavoni Elisa , Napolitano Daniele , Durini Eleonora , Strazzeri Martina , Lombardi Maria Teresa , and Schifano Elisabetta

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Cancer Clinical Research Coordinator Associate - Blood & Marrow Transplantation and Cell Therapy (BMT-CT)

Researchers are driven by possibility. As a Cancer Clinical Research Coordinator Associate - Blood & Marrow Transplantation and Cell Therapy (BMT-CT), you will be a central force in our mission to ensure equity of care across the globe. With an opportunity to continue your professional development and interact with some of the top minds in medicine, your possibility-driven approach will have a profound impact on the lives of patients. As we work to make sure everyone has access to safe, innovative treatments, our NIH ranking and the backing of Stanford Medicine will help ensure that you have the resources you need to succeed. Join us at Stanford School of Medicine, where we are better with you.

Level: Entry Level
Travel: Minimal (if any)
Salary: $63K-$96K

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Assistant Clinical Research Coordinator leads to Clinical Research Coordinator Associate
Clinical Research Coordinator Associate leads to Clinical Research Coordinator 2 or Medical Degree (MD) or Physician Assistant (PA) Program Medical Degree (MD) or Physician Assistant (PA) Program
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Cancer Clinical Research Coordinator Associate – VBMT (Hybrid)

The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. We seek a Cancer Clinical Research Coordinator Associate -Blood and Marrow Transplantation & Cell Therapy (BMT-CT) to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach. Given the SCI’s mission, breadth, and depth, it employs over 320 staff members in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth. The Cancer Clinical Trials Office (CCTO) is an integral component of the Stanford Cancer Institute since the vital work performed there enables our adult and pediatric cancer centers to translate research from the laboratory into the clinical setting. You will be working with an unparalleled leading-edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena.

Reporting to the Clinical Research Manager of Blood & Marrow Transplantation and Cell Therapy (BMT-CT), the Clinical Research Coordinator Associate will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to to manage data, enroll and follow patients on trial, and assist with regulatory and financial requirements of the trials. We are seeking candidates with excellent organizational, communication (written and verbal) and interpersonal Skills. Our staff run toward challenges, and you will have a demonstrated history of doing the same with a high degree of professionalism, initiative and flexibility. Responsibilities include patient enrollment and follow up, and data and regulatory management.

Core duties include:

Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out.
Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
Coordinate collection of study specimens and processing.
Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed.
Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
Participate in monitor visits and regulatory audits.
Hybrid Position.

* - Other duties may also be assigned.

DESIRED QUALIFICATIONS:

Knowledge of the principles of clinical research and federal regulations.
Familiarity with IRB guidelines and regulations.
Previous experience with clinical trials.

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

EDUCATION & EXPERIENCE (REQUIRED):

Two-year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

Strong interpersonal skills.
Proficiency with Microsoft Office.
Knowledge of medical terminology.

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PHYSICAL REQUIREMENTS*:

Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

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Occasional evening and weekend hours.

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Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu .

The expected pay range for this position is $27.88 to 36.54 per hour. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

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The pandemic has made it difficult for me to transition back into research. Once I started working at Stanford of Medicine, I immediately felt welcomed and supported. This institution has provided me with great opportunities to explore different kinds of research that can contribute to the field of precision medicine. It’s a great place for growth and to have my goals supported. –Guillermina Michel, Clinical Research Coordinator Associate – Anesthesia

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CLINICAL RESEARCH COORDINATOR

Durham, NC, US, 27710

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Operations: Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI). May train or oversee others. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Maintains study level documentation for international studies. May develop resources and tools for management of international studies, and/or coordinate with other entities or offices. Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding. May train others. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Maintains participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. May train or oversee others. Employs strategies to maintain retention rates. Evaluates processes to identify problems with retention. May train or oversee others. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee others. Screens participants for complex studies (e.g., procedural and interventional studies). May train or oversee others. Develops or helps develop SOPs. May train or oversee others. Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring complex procedures. May train or oversee others. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). May train or oversee others. Conducts and plans for complex study visits. May train staff. Leads meetings that are multidisciplinary, including those with complex objectives. Ethics: Identifies all AEs, and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. May train or oversee others. Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May train or oversee others. Develops consent plans and documents for participants in a variety of studies. May train or oversee others. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. May train or oversee others. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others. Data: Enters and collects data. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review RDSPs for multiple study protocols. Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). May train or oversee others. Independently uses and implements technology to enhance productivity or process. May train or oversee others. Science: Assists with or contributes to the development of funding proposals. Independently conducts literature searches and reviews. Using scientific proposals from the PI, develops research protocols. Demonstrates a basic understanding of the elements of research study designs. Contributes to the development of scientific publications or presentations. Serves as an author on poster presentations or publications. Study and Site Management: Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits. Uses required EMR functionalities to manage participants and study visits. May train others. Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information. May train others. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations. For studies with complex supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast staffing needs. May train or oversee others. Ensures that studies are conducted in compliance with institutional requirements and other policies. Follows, and may develop or implement, protocol-specific systems and documents including process flows. May train or oversee others. Prepares studies for closeout and document storage. May train or oversee others. Leadership: Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Type of Research: The Clinical Research Coordinator (CRC) will serve as the primary coordinator for multiple complex studies within the Division of Rheumatology. The coordinator will conduct clinical research studies in this area of focus, as well as serve as back up in other Rheumatology studies as needed. The coordinator will be responsible for all day to day study activities (such as subject consent and enrollment, data collection and entry, participant compensation, study monitoring activities, etc.), and will work with the Division Lead to manage regulatory tasks (such as study start up and close out, IRB tasks, etc.). Special/Preferred Skills: The person in this role must have organizational skills, communication skills including excellent writing skills, the ability to handle multiple assignments simultaneously, technology skills, medical terminology, and a basic understanding of clinical medicine. They must be able to flex with the demand of work schedules and timelines. They must demonstrate excellent attention to detail. They must be able to manage, work with, and support multiple stakeholders with different practice styles in a productive manner, and willing to learn new and complex skills as needed. The coordinator must be resourceful, able to work independently, and to problem-solve on a daily basis. The preferred candidate will have Duke clinical trial experience and a desire to expand their knowledge and to share knowledge in an academic setting.

Minimum Qualifications

Completion of an Associate's degree

Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobsat Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Nearest Major Market: Durham Nearest Secondary Market: Raleigh

Duke is an Affirmative Action / Equal Opportunity Employer committed to providing employment opportunity without regard to an individual’s age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status. Read more about Duke’s commitment to affirmative action and nondiscrimination at hr.duke.edu/eeo.

COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK

Parliament, Office Building, Building, Architecture, Urban, Postal Office, Grass, Plant, City, Town

Labor Relations Coordinator

Columbia University Human Resources
Columbia University Medical Center
Opening on: Apr 2 2024
Job Type: Officer of Administration
Regular/Temporary: Regular
Hours Per Week: 35
Salary Range: $75,000 - $90,000

Position Summary

The Labor Relations Coordinator will work to ensure there is a strong and high-quality relation with represented employees, while advancing the University's overall strategic goals and reflecting sound principles of human resources management. Reporting to the Director of Labor Relations (DLR), the Coordinator will be tasked with overseeing the reporting on Casuals, temporary employees, and upgrades within the bargaining unit.

The Coordinator will assist with third-step grievances, discipline, and contract interpretation; manage the 1199/SSA Child Care Subsidy Fund, Educational Training Assistance Program, 2% Merit Wage Bonus, and Layoff and Recall Pool process. This individual will also oversee the monthly Jobs Committee. They will work closely with HR Business Partners and Generalists, Departmental Administrators/Managers of CUMC departments, members of the Labor Relations team, and will collaborate with other University offices regarding unionized staff. Additionally, they will assist with other related human resources projects and assignments as required.

Responsibilities

Reviewing, counseling, negotiating, investigating, preventing and settling any union employee workplace grievances;
Interpreting union contracts and agreements which deal with wages, hours, working conditions and all other matters within the purview of the agreements affecting labor relations, employee relations and human resources activities.
1199/SSA Child Care Subsidy Fund,
2% Merit Wage Bonus,
Research Project Safety Protocol,
Educational Training Assistance program.
Developing, reporting, promoting, implementing, managing and maintaining effective procedures, and practices.
Coordinating and preparing for the monthly 1199 SSA/CUMC Jobs Subcommittee meeting.
Serves as the liaison between CUMC departments and 1199/SSA union for the purpose of developing and resolving all aspects of the union contract and ensuring compliance and adherence to the Columbia University policies
All other duties as assigned or required.

Minimum Qualifications

Bachelor's degree or equivalent in related experience required, 3-5 yrs of related work experience
Excellent communication, interpersonal, organizational and presentation skills.
Must be able to take initiative with the ability to be a team player.
Ability to work in a fast-paced environment.
Excellent computer skills, specifically in Microsoft Office applications and human resources information systems.
Excellent analytical and problem solving skills.

Preferred Qualifications

Ability to develop and maintain strong business relationships and the demonstrated ability to collaborate with all levels of HR and business management.
Excellent communication skills and the ability to negotiate and influence others.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.

Commitment to Diversity

Columbia university is dedicated to increasing diversity in its workforce, its student body, and its educational programs. achieving continued academic excellence and creating a vibrant university community require nothing less. in fulfilling its mission to advance diversity at the university, columbia seeks to hire, retain, and promote exceptionally talented individuals from diverse backgrounds. , share this job.

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Clinical Research Coordinator

Administrative manager, communications officer.

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Clinical Research Coordinator

🔍 school of medicine, stanford, california, united states.

DESIRED QUALIFICATIONS:

Bachelor’s Degree in biology, chemistry, public health or other health-related field.
1-2 years working in clinical research.
Ability to work fast and efficiently within time constraints.
Ability to work independently and comfortably with study participants .
Prior data entry and management experience.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

General knowledge of medical terminology.
Ability to work with human study participants as well as in a team
Attention to detail in data collection and excellent organizational skills
Ability to work under deadlines with general guidance
Strong written and oral communication skills
General computer skills and ability to quickly learn and master computer programs such as REDCap, Microsoft Office
Ability to interpret, adapt, and apply guidelines and procedures

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

PHYSICAL REQUIREMENTS*:

Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

WORKING CONDITIONS:

Occasional evening and weekend hours.

WORK STANDARDS:

Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu .

The expected pay range for this position is $27.88 to $36.54 per hour.

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website ( https:/lcardinalatwork.stanford.edu/benefits-rewards ) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Schedule: Full-time
Job Code: 1013
Employee Status: Regular
Requisition ID: 102177
Work Arrangement : Hybrid Eligible

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