Clinical Research Coord Assoc

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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 may provide study coordination for multiple clinical research studies depending on complexity 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 this position 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 with a reasonable degree of proficiency. This 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. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

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*

Characteristic Duties and Responsibilities:
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

Additional Responsibilities:

• Perform moderately complex study procedures with accuracy.
• Recruit, screen, and obtain consent for potential research subjects for studies within the department.
• Support in-person and remote consenting, enrollment, and follow-up tasks as needed and requested by participants and the study team.
• Collect, enter, and manage data.
• Triage simple subject concerns and issues appropriately.
• Assess studies for execution and troubleshoot potential implementation issues.
• Schedule, assist with preparation, and attend study initiation meetings, audits, and monitor visits.
• May work with CTSUs to reconcile financial accounts for study participants.
• Assist with local quality control efforts.
• May create recruitment plans that address the needs of the study population and develop materials for IRB submissions that will aid in recruitment.
• Assist in preparing for internal and external audits and reports, such as regulatory compliance and sponsor milestones.
• Submit protocols, amendments, and continuing reviews to Institutional Review Boards.

Required Qualifications*

     CRC Associate

• Bachelor's degree in Health Science or an equivalent combination of related education and experience.
• 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 )
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.

     CRC Technician

• Associate degree in Health Science or an equivalent combination of related education and experience.
• ONE of the following:
  • Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
  • An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
  • Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.

     CRC Assistant

• High school diploma or GED is necessary.
  

Desired Qualifications*

•          4+ years of direct related experience

Work Schedule

This is a full-time position, Monday-Friday, 40 hours per week.

Work Locations

Onsite work is required.  This position may be eligible for remote and/or flexible work opportunities at the discretion of the hiring department.  Flexible work agreements are reviewed annually and are subject to change dependent on the business needs of the hiring department, throughout the course of employment.  

Underfill Statement

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

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.