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*

Contribute to the development of process and tools 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

• Provide direct oversight for a 5-year federally-funded multi-site clinical trial
• Coordinate submission of IRB applications, continuing reviews, amendments, adverse events, proposals, and award agreements to IRB and other regulatory agencies for approval
• Ensure compliance with all regulatory guidelines and relevant policies (federal, Michigan Medicine, IRB, departmental)
• Manage OnCore billing calendar
• Work independently to manage all aspects of clinical research study activities
  • Screen and recruit patients, collect data, and conduct follow-up
  • Create and manage research databases
  • Monitor subjects closely and report any issues or adverse events to investigator and IRB, if needed
• Establish operational objectives and timelines
  • Review and evaluate study progress on an ongoing basis to ensure projects are completed within specifications
  • Develop and implement quality assurance processes
  • Manage project resource needs within specified timelines and budget
• Act as liaison between investigators, study coordinators, and Trauma Burn ICU to manage on-boarding of new research projects and co-enrollment of patients who are  eligible for multiple studies
  •  Ensure all research activities within TBICU Department are in compliance with regulatory guidelines and departmental policies
• Manage multiple new studies, quality improvement projects, and long-term data projects
  • Submit new IRB applications, develop research protocols, create consent forms and source documents, manage billing calendar
  • Create research databases; extract relevant study data from MiChart and other large patient databases
  • Prepare manuscripts for publication; analyze and report data

Required Qualifications*

• CRC Governance Committee Review and Approval
• 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.

Senior:

• Minimum of 5 years directly related experience in clinical research and clinical trials is necessary.

Intermediate:

• Minimum of 3 years directly related experience in clinical research and clinical trials is necessary.

Desired Qualifications*

Senior:

• 9+ years of direct related experience

Intermediate: 

• 6+ years of direct related experience

Underfill Statement

This position may be underfilled at the CRC-Intermediate title based on selected candidates’ qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

Additional Information

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 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.

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.

Vaccine Requirements

COVID-19 vaccinations are required for all students, faculty and staff working in the following areas: Michigan Medicine including the Medical School, Dental School, University Health Service or the Mary A. Rackham Institute.  This includes those working remotely and temporary workers.   More information on this new policy is available on the U-M Health Response.

U-M EEO/AA Statement

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