This clinical research coordinator (CRC) position will provide study coordination for multiple clinical research studies that range from moderate to complex. Responsibilities include screening, recruitment, data entry, coordinating care with the clinical team, attend research procedures, adverse event reporting, IRB submissions and scheduling of follow up visits. 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 can discern when to escalate issues needing additional intervention. 

• Under the direction of the Clinical Research Manager and Study PI ensure clinical research related procedures are completed in accordance with GCP.
• Screen, consent, retain and follow patients according to the study protocol
• Coordinate and schedule research visits and procedures
• Serve as primary point person for research participants
• Work directly with sponsors in a professional manner serving as the liaison between study team and sponsor
• Data collection, source management, data entry and query management
• IRB and regulatory submissions
• Other responsibilities as directed by PIs and Clinical Research Manager

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 the Clinical Research Manager.

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) 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.)
• Minimum 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. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)  or  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. or 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.  

Associate Level:

• 4+ years of direct related experience
• Knowledge of EPIC and Oncore 

Technician Level:

• Bachelors degree in Health Science or an equivalent combination of related education and experience is desirable. 
  An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable. 

This is a full time position that is performed onsite at the Ann Arbor Hospital. 

This position may be underfilled at the CRC-Technician title 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 employment opportunity employer.

About University of Michigan - Ann Arbor

A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.

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