This clinical research coordinator (CRC) position will provide study coordination for multiple clinical research studies that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that the applicant is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies including REDCap, eResearch, OnCore, and MiChart with a reasonable degree of proficiency. Applicants to this CRC position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. They also understand core concepts of consent, ALCOA-C, ICH GCP, AEs and SAEs, ORIOs, regulatory binders, and timely documentation in case report forms and eCRFs. 

Independent knowledge, skills, and abilities within all 8 competency domains is expected:

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

Supervision Received: This position reports directly to CRC-Lead.

Supervision Exercised: None
 

Associate Level:

• Bachelor’s 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) and must be achieved by 01/01/24.  After 01/01/24, certification is required within six months of date of hire.  
• Minimum of 2 years of directly related experience in clinical research and clinical trials is necessary. 

Technician Level:

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary.
• ?Minimum 1 year of directly related experience in clinical research and clinical trials is necessary.

Assiatnat Level:

• High school diploma or GED is necessary

• 4+ years of direct related experience

The work schedule is generally when patients are in clinic on weekdays from 8 AM to 5 PM, but can be flexible. You will work as part of a team of 5 coordinators who can cover for each other. A significant portion of digital work (screening patients, phone calls, data entry, regulatory updates) can be done from home if needed, so that several members of the team work up to 16 hours / week from home. Covering for each other so that at least one coordinator is in the office each weekday allows for flexible work and being able to meet with eligible patients during clinic. This job and team are welcoming to people with families, people of color, LGBTQ+ people, and people with disabilities. 

This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates’ qualifications.

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. 

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.

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.

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.

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

U-M COVID-19 Vaccination Policy

COVID-19 vaccinations, including boosters when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine.  This includes those working remotely.   More information on this new policy is available on the Campus Blueprint website or the UM-Dearborn and UM-Flint websites.