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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

The REMEDY team at the University of Michigan (UM) manages the vast portfolio of surgical clinical trials for the Department of Cardiac Surgery. The team consists of varying levels of coordinators dedicated to advancing healthcare to improve outcomes for patients. Our collaborators include investigators from other departments within UM, industries, and Universities. We specialize in multi-center, including international, device trials as well as outcomes research, drug trials, and investigator-initiated studies. As we continue to expand our portfolio, we are looking for detail orientated, highly motivated, compassionate individuals to join our team.

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. 

Responsibilities*

     Characteristic, Duties and Responsibilities:

Scientific Concepts and Research DesignEthical Participant Safety ConsiderationsInvestigational Products Development and RegulationClinical Study Operations (GCPs)Study and Site ManagementData Management and InformaticsLeadership and ProfessionalismCommunication and Teamwork

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      Responsibilities will include, but are not limited to:

Perform moderately complex study procedures with accuracyTriage simple subject concerns and issues appropriatelyAssess studies for execution and troubleshoots potential implementation issuesSchedule, assist with preparation, and attend study initiation meetings, audits, and monitor visitsComplete simple to moderately complex data collection during study visitsMay assist in CRF developmentComplete new eResearch applicationsMaintain essential regulatory documents as outlined in the ICH-GCP guidelinesGather participant approval via informed consentPrepare and participate in internal and external auditsIdentify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs), and understands how to report appropriatelyCommunicate with study participants such as sending study correspondence via mail or emailSchedule subjects for research visits and FU appointmentsCheck study calendar for completion of study proceduresUtilize documents and systems to track recruitment and retention of participantsGain appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assignedWilling to learn and use available technology and systems to accomplish job requirementsUnderstand the disease process per programAttend and participate in all training classes assigned to this level.Assists with training activities of staff and othersPerform other related duties as assigned

Supervision Received:  This position reports directly to the Clinical Research Manager for the Department of Cardiac Surgery.

Supervision Exercised: None.

 

Required Qualifications*

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.

Desired Qualifications*

Bachelor's 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.

Work Schedule

Hours/Week: 40 hours

Shift/Hours/Days: Days, occasional evening, potential weekends, potential on call

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.