Job Description

This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the  Michigan Medicine CRC Career Ladder is required. This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the  Michigan Medicine CRC Career Ladder is required. 

• Assisting in clinical research studies including patient screening and enrollment; study medication accountability; database management; coordination of study visits, labs and procedures; documentation and communication with physicians, study coordinators and sponsors. Accurate and timely distribution of research kits to sites and subjects.
• Scheduling of experiments and the collection, processing and analysis of data. Collects specimens and monitors subjects. Assists in the reporting of test results. Demonstrates accurate identification and reporting of AEs, SAEs, deviations and ORIOs.
• Coordinates the submission of clinical study materials to IRB and other regulatory agencies for approval. Prepare data sets for statistician and/or analysis. Attend investigator and coordinator meetings, serve as a resource and contact person for active protocols.

Knowledge of 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 receives direct supervision and reports directly to Faculty Principal Investigator and/or CRC - Project Manager.

Supervision Exercised: None

Clinical Research Assistant: 

• High school diploma or GED is necessary.

Clinical Research Technician:

• 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.

Clinical Research Assistant: 

Associate 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. 

Clinical Research Technician:

Bachelors degree in Health Science  or an equivalent combination of related education and experience is desirable. An u nderstanding of medical terminology , e xperience 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 Mon-Fri., hybrid (85% office, 15% remote) position. 

This position may be underfilled at the CRC-Assistant title based on selected candidate's qualifications.

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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