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.

The department of Radiology is seeking an experienced clinical research professional to support and manage clinical research activity. This clinical research coordinator (CRC) position will provide support, oversight, and/or project management for all clinical research studies in the department of Radiology. This position will also oversee the intake and review process for clinical trials requesting the use of Radiology's resources for clinical research.

Coordinator experience and mastery of all job duties on the Michigan Medicine CRC Career Ladder is required. This position has achieved mastery in all aspects of clinical research management. This position has oversight for clinical research projects and has responsibility for ensuring that they are completed within specifications. This position establishes operational objectives and assignments and defines and manages project resource needs including project staff. Employees in this classification typically analyze, compare, and evaluate various courses of action and have the authority to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities. Primary activities and decision-making authority are predominantly performed independently affecting business operations to a substantial degree. This position applies skills and knowledge to leading and directing others. It is important that candidates have experience in supervision and a vision for mentorship and coordinator training.

This position may be underfilled at the CRC-Lead or CRC-Senior titles based on selected candidates' qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

Set-up unit wide systems or policies and manage a team of clinical research professionals (or portfolios) in 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

Department specific duties include: 

1. Establishing standards for clinical research studies based on ethics, regulatory compliance, and best practices. 
   1. Education/training of personnel and investigators on expectations.
   2. Internal reviews of trials for compliance.
2. Maintaining and operating a process to review all Michigan Medicine trials requiring Radiology resources. 
   1. Guiding a dedicated staff member
   2. Maintaining a database of trials
   3. Reviewing/approving proposals
   4. Communication with the clinical trials support units and/or study teams
   5. Financial management and invoicing trials for this review service
3. Manage effort for team of coordinators
   1. Budgeting effort for potential trials
   2. Effort allocation for trials (and associated financial details)
4. Coordination across Michigan Medicine units for trial support
   1. Point person for communication with clinical trials support units
   2. Trial budgeting
   3. Investigator training/onboarding
   4. Support for trials involving for investigational devices and drugs. 
5. Other duties as assigned.

Mandatory for all titles: 

• CRC Governance Committee review and approval.  
• 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.)

Clinical Research Project Manager: 

• Master's Degree in Health Science or an equivalent combination of related education and experience is necessary. 
• Minimum 6 years of directly related experience in clinical research and clinical trials is necessary.  (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)

Clinical Research Coordinator Lead or Senior (Underfill):

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary
• Minimum 5 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)

Clinical Research Project Manager: 

• Project Management certification
• Supervisory experience
• 9+ years of direct related experience

Clinical Research Coordinator Lead (Underfill):

• Master's Degree in Health Science or an equivalent combination of related education and related experience is desirable.
• 9+ years of direct related experience

Clinical Research Coordinator Senior (Underfill):

• 9+ years of direct related experience

Weekdays (Monday-Friday), 9am-5pm

Victor Vaughn Building

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.

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.

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 employment opportunity employer.