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Responsibilities*

Provide data management and study coordination for clinical research trials (investigator initiated and commercially sponsored trials). Collect quality data in timely fashion recording data on case report forms and entering into database; Work closely with staff and biostatistical core to ensure compliance and assist in the analysis of data; Register patients to trial in Clinical Trials Database/with Sponsor after confirmation of eligibility; Abstract data on patients from various sources; Participate/Organize Site Visits (UofM) ; Attend Investigator Meetings (pharmaceutical studies); Ensure compliance with GCP, FDA regulations, ICH regulations, and IRB policies and procedures; Act as liaison with Regulatory Team, Study Team, federal/industrial sponsors; Management of the Study (maintain up to date protocol specific CRFs, etc); Obtain source documents for CRF completion; Prepare for Audits - internal (QARC) and external (FDA, Industry); Data Safety Monitoring preparations for PRC Executive Committee, Sponsors, Cooperative Groups, FDA; Prepare for and participate in Monitoring Visits; Prepare Ad Hoc Reports, Handle PPI special requests; Schedule/Prepare/Attend study closeout meetings; Data Entry; Specimen handling and shipping.

Required Qualifications*

Qualifications for Clinical Research Coordinator:

Bachelor's degree in Science or a Health Science related field with 1-3 years’ data management, direct clinical research experience, or equivalent work experience. To be successful in this position the candidate should have a working knowledge of GCP and FDA regulations governing clinical research. Candidate must possess IT proficiency, database experience, familiarity with medical terminology, excellent written and oral communication skills and self-motivation. Candidate must demonstrate the ability to thrive in a dynamic, fast paced team environment but must also be able to work independently under limited supervision. The candidate must possess interpersonal skills with exceptional attention to detail and the willingness to contribute in a team setting. Exceptional organizational skills required. Previous research/data management experience required.

Qualifications for Clinical Subjects Coordinator:

Bachelor's degree in Science or a Health Science related field. Candidate must possess IT proficiency, database experience, familiarity with medical terminology, excellent written and oral communication skills and self-motivation. Candidate must demonstrate the ability to thrive in a dynamic, fast paced team environment but must also be able to work independently under limited supervision. The candidate must possess interpersonal skills with exceptional attention to detail and the willingness to contribute in a team setting. Exceptional organizational skills required. Previous research/data management experience preferred.

Underfill Statement

The Clinical Research Coordinator position is intended for experienced research personnel. Candidates will be considered for entry level position of a Clinical Subjects Coordinator, if no candidates are selected at the Clinical Research Coordinator level.


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.

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.

Application Deadline

Job openings are posted for a minimum of seven calendar days. This job 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.