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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.

Job Summary

As part of the strategic research initiative, Fast Forward Clinical Trials (FFCT) is engaging the entire UMHS in creating a new model to improve clinical care, value, and health outcomes by successfully executing a diverse portfolio of high-quality clinical trials. This new model entails an organizational structure of local service CTSUs, central infrastructure, and governance oversight.  CTSUs will provide a professional environment of expert personnel accessible to all investigators, especially early-career faculty. The Medical School Office of Research and the Michigan Institute for Clinical and Health Research (MICHR) are responsible for the central services, providing enterprise-wide standards, policies, and common infrastructure that can be leveraged by the CTSUs and study teams.  The entire system is governed by the Medical School Office of Research in partnership with the Clinical Trials Subcommittee of the Research Board of Directors

Responsibilities*

Basic Function and Responsibility

In collaboration with the CTSU Medical Director, CTSU Administrator, Finance Team Lead, Executive Committee and ACCST faculty, the Research Study Coordinator will provide a value added service assisting ACCST faculty with study coordination of any clinical trials within the ACCST CTSU as needed.  This position will be part of a study coordinator pool providing support to junior faculty as well as established study teams for clinical trials. The coordinator will be available to assist study teams with study coordinator activities such as screening, collecting and managing patients and laboratory data for clinical research subjects, data entry, and regulatory management.  Additionally, the research coordinator will assist, if needed in preparation of IRB submissions, billing calendars, and other related duties as needed.  

Characteristic Duties and Responsibilities

Assist with aspects of trial coordination including screening, collecting and managing patients and laboratory data for clinical research subjects.  Screens and has oversight for the recruitment of subjects, supervises the scheduling of experiments and the collection, processing and analysis of data.

Prepare IRB submissions including initial as well as scheduled continuing reviews, progress reports, adverse event and ORIO reports and become subject matter experts for both local and commercial IRB submissions.  

Work collaboratively with ACCST finance team providing consultation on budget specifications and billing calendar creation, collaborate on post-award account reconciliation and close out. 

Provide support for FDA audits.

Support other clinical research staff in ACCST in study coordination activities during ‘off hours’ and weekends.

Supervision Exercised

Functional supervision is received from the principal investigators and co-investigators.  This position will work in collaboration with other study team members, including study coordinators outside of the CTSU, along with the pre and post award finance team.  Administrative supervision is received from the CTSU Administrator.  

Required Qualifications*

  • Bachelor degree in a science or health-related field or equivalent education and experience and 1-3 years’ minimum experience as a study coordinator or study monitor.    
  • Demonstrated knowledge of medical terminology.
  • Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner.
  • Ability to work varied work hours. This position requires some evenings and every other weekend.
  • Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
  • Excellent computer skills including proficiency in Microsoft software applications.
  • Excellent organizational skills including the ability to multi-task and work well under time constraints and deadlines. 
  • Experience and understanding of start-up process related to clinical trials.
  • Certification through ACRP or SoCRA or willingness to become certified within two years of date of hire.

Desired Qualifications*

  • Demonstrated knowledge of medical terminology specifically related to the areas of cardiovascular and hematology.
  • Familiarity with Epic, Mi-Chart and e-Research applications.
  • Experience with IRB application process.
  • Demonstrated understanding of clinical research; understand compliance issues related to human subject research, knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations.
  • PEERS, CITI or NIH Protection of Human Subjects Training Certification.

Work Schedule

Shift/Hours: This is a full time, 40 hour work week position.  Primarily 2 pm-10:30 pm M-F, however variability/flexibility will be required. Coverage on an occasional weekend is possible.

Additional Information

Under FLSA, incumbents in this position meet the criteria for exempt status.

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.

U-M EEO/AA Statement

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