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.

The Division of Gastroenterology and Hepatology has an immediate need for a full time Clinical Research Subjects Associate to conduct ongoing observational and interventional studies in metabolic liver disease and DILI under the direct supervision of the PI and in conjunction with other study team members. Studies are sponsored by NIH and industry.  The CRC associate will directly report to the PI and interface with IRB, billing office, research administration, external DCC, and study sponsors. Outstanding interpersonal and communication skills are required. 

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.

Why Join Michigan Medicine?

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

Responsibilities*

• Inputting and managing data into CRF's, scheduling and conducting appointments. Regular phone and e-mail contact with faculty, external parties, administrative personnel
• Filing and maintaining research and regulatory documents, written correspondence with IRB, research office, sponsors, and maintaining a freezer repository of serum samples
• Meetings with DCC, biorepository, and study conference calls
• Weekly research team meetings with PI, other coordinators and students
• Searching the EMR for potential DILI patients and clinical trial patients using natural language processing and computer algorithms

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 a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator.

Supervision Exercised: None

Required Qualifications*

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) and must be achieved by 01/01/24.  After 01/01/24, certification is required within six months of date of hire.  
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. 
• Background in medical field and knowledge of medical terminology required.
• Demonstrated ability to prioritize and multitask;  outstanding organizational skills.
• Excellent computer and IT skills required and versed in Word, Excell, Pagemaker, databases.

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

Assistant Level: 

• High school diploma or GED is necessary.

Desired Qualifications*

Assoicate Level:

• 4+ years of direct related experience.
• Masters degree in Public Health, clinical research or biostats preferred.
• Extensive knowledge of regulatory, budget, sponsor and administrative issues in conducting NIH and industry studies.
• Familiarity with conducting statistical analyses preferred.

?An understanding of medical terminology, experiencein a large complex health care setting, ability to effectively communicatewith staff and faculty of all levels, and knowledge of university policies and procedures is desirable

Technician Level:

• Bachelor’s degree in Health Science or an equivalent combination of related education and experience is desirable.

Assistant Level:

• Associate Degree in Health Science or an equivalent combination of related education andexperience is desirable

Work Schedule

Monday-Friday 

Underfill Statement

This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates’ qualifications.

Additional Information

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.

U-M EEO/AA Statement

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

U-M COVID-19 Vaccination Policy

COVID-19 vaccinations, including one booster when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine.  This includes those working remotely and temporary workers.   More information on this new policy is available on the U-M Health Response website or the UM-Dearborn and UM-Flint websites.