How to Apply

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Summary

This clinical research coordinator (CRC) position with the Department of Anesthesiology, Neuroscience Division, will provide study coordination for multiple clinical trials with National Institutes of Health (NIH) funding, industry-sponsored funding, and investigator-initiated clinical research studies.

This position will independently complete IRB applications, amendments, develop supporting documents as needed. This position will assist with clinicaltrials.gov registration and maintenance.

This position will work directly with study sponsors and other key stakeholders to meet all protocol-specific requirements.

This position will coordinate and/or oversee all aspects of clinical trial visits including screening for eligibility, obtaining informed consent, scheduling/coordinating and attending study visits, working with the study teams to identify and track adverse events, protocol deviations, OnCore registration and tracking, placing MiChart orders, and processing human subject incentive payments.

Supervision Received: This position reports directly to the Clinical Research Project Manager.

Supervision Exercised: This position will provide functional supervision of a CRC Technician.

This position will generally be in-person and is based out of University Hospital. There may be an opportunity for occasional remote work.

This is a term-limited position through July 2025, with the possibility of an extension.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Responsibilities*

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork

Clinical Coordinator Responsibilities:

• Lead patient and participant screening efforts across multiple NIH, industry-sponsored, and investigator-initiated studies.
• Prepares for and attends site monitor visits and audits.
• Process human subject incentive payments.

Data Coordinator Responsibilities:

• May create and manage local databases.
• Assist with clinicaltrials.gov registration, maintenance, and reporting.
• Work with study sponsors to ensure accurate and timely data entry and query resolution.

Regulatory Coordinator Responsibilities:

• Oversees regulatory documentation for quality assurance.
• Prepares for and attends site monitor visits and audits.
• Coordinates regulatory compliance responsibilities, including: Identifies, documents, and assists in the IRB application submission, amendments, scheduled continuing reviews, reporting of protocol deviations, adverse event (AE/SAEs) and other reportable information and occurrences (ORIOs) reporting per protocol

Administrative Responsibilities:

• Act as a liaison or point of contact between investigators, research teams, sponsors, other internal and external departments.
• Reviews study forms database, regulatory files, and all study related work for completion and accuracy.
• Provides mentorship of other clinical trial staff; maintains certification.

Required Qualifications*

• Bachelors degree in Health Science or an equivalent combination of related education and experience is necessary.
• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior to applying)
• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. (Please review SOCRAs definition of a Clinical Research Professional for qualifying experience prior to applying.)

Desired Qualifications*

• 6+ years of direct related experience
• Previous direct experience working on NIH or industry funded trials.
• Previous direct experience working on clinical trials that enroll vulnerable patient populations.
• Previous direct experience working on clinical trials that enroll healthy human participant volunteers.
• An understanding of medical terminology, experience in a large complex health care setting, the ability to effectively communicate with staff and faculty off all levels, and knowledge of university policies and procedures.

Work Schedule

Monday - Friday, 7:30am - 4:00pm

Additional Information

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

Please note: This is a 1 year term-limited position through July 2025, with the possibility of an extension, based on need and available funding. At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

Job Detail

Job Opening ID

251142

Working Title

Clinical Research Coordinator Intermediate - Term Limited

Job Title

Clinical Research Coord Inter

Work Location

Ann Arbor Campus

Ann Arbor, MI

Full/Part Time

Full-Time

Regular/Temporary

Regular

FLSA Status

Exempt

Organizational Group

Medical School

Department

MM Anesthesiology Department

Posting Begin/End Date

7/02/2024 - 7/09/2024

Career Interest

Research