This clinical research coordinator (CRC) position may provide study coordination and/or project management for multiple clinical research studies of any complexity. 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.

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.

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems.  In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Characteristic Duties and Responsibilities:
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

Working with a multidisciplinary team and across external study sites throughout the U.S., organizing, developing, and expanding research networks of clinicians inventing and refining new models of care for patients recovering from critical illness.  Organize and expand networks of clinicians collaborating with our project

This will involve working in and/or leading several significant projects:

• Organizing and expanding networks of clinicians, inventing and refining new models of care for patients recovering from critical illness
• Work collaboratively with the CTSU team and external study sites by maintaining a good rapport and communication with research teams and faculty, as well as patients and families
• Recruiting, retaining, and surveying cohorts of patients to understand variation in the forms of healing

This project manager will also partner with the project PI on the coordination of the data collection from multiple sources, and the preparation and maintenance of all regulatory materials. Other essential responsibilities include, but are not limited to:

1. Plan, coordinate, and conduct grant writing;
2. Write and edit sections of grants;
3. Create and implement a project management plan and budget for research projects.
4. Help coordinate team members' schedules and communications;
5. Provide support services for the preparation of reports and manuscripts
6. Provide support for IRB audits and monitor visits, including the following:
   1. Assist in the preparation of IRB amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports
   2. In coordination with other CTSU staff, communicate with sponsors concerning progress of clinical research, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures
   3. Act as liaison between study team and sponsors, IRB, federal, state, and University officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements and other regulatory issues
   4. Oversee and train other research staff in the research projects

Supervision Received:
This position reports directly to the division Administrative Director and the Faculty Principal Investigator.

Supervision Exercised:

This position manages a portfolio of multi-site clinical research in which the University of Michigan is the lead center.

Interest in issues of health promotion; personal commitment to high quality work; excellent communication skills, both oral and written in the English language; attention to detail; strong organizational skills; excellent interpersonal skills; the ability to multi-task and prioritize efforts; the ability to work both as part of a team and individually while meeting deadlines; and a commitment to improving the care and lives of children. Experience with REDcap is required.

Specific Skills: At least one of the following is required:

• Experience with the administration of complex surveys or clinical trials
• Substantial experience in complex project management

CRC - Project Manager

• CRC Governance Committee review and approval  
• Master'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) 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 orACRP prior to applying.)
• Minimum 6 years of directly related experience in clinical research and clinical trials is necessary.  (Please review SoCRA?s Definition of a Clinical Research Professionalfor qualifying experience prior to applying.)

CRC - Lead

• 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) 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 orACRP prior to applying.)
• Minimum 5 years of directly related experience in clinical research and clinical trials is necessary.  (Please review SoCRA?s Definition of a Clinical Research Professionalfor qualifying experience prior to applying.)  

CRC - Senior

• 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) 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 orACRP prior to applying.)
• Minimum 5 years of directly related experience in clinical research and clinical trials is necessary.  (Please review SoCRA?s Definition of a Clinical Research Professionalfor qualifying experience prior to applying.)  

CRC - Project Manager

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

CRC- Lead

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

CRC - Senior

• 9+ years of direct related experience

The position is full-time. The work schedule will typically be Monday-Friday, 8-hour shifts. However, flexibility on weekends and evenings may be required depending on study needs.

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 the CRC-Lead or CRC-Senior titles based on selected candidates, qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

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.