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Job Summary

The Clinical Research Coordinator (CRC) will provide a valuable service assisting faculty with study coordination of clinical trials and observational studies.  The CRC will be available to assist with study coordinator activities such as screening, consenting, and enrolling subjects; collection and management of patient and laboratory data; IRB application preparation, and regulatory management.  Additionally, the CRC will manage audits and monitoring visits, as well as other duties as needed.  The position will likely include travel to off-site locations and some flexibility in schedule due to meetings and scheduled study activities.

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.

Responsibilities*

  • Oversight of the recruitment, enrollment and retention of subjects
  • Develop and implement effective study recruitment strategies 
  • Supervise the scheduling and screening of potential patients
  • Update and maintain IRB
  • Monitor study progress toward goals and modify resources as needed 
  • Maintain all study essential documents including responsible completion of all case report forms and accurate source documentation
  • Act as a liaison between clinical research team and sponsor, as well as between patient, investigator, and regulatory agencies
  • Oversight and responsible for research billing payment, invoices and patient reimbursement/stipends for studies
  • Work with internal resources and sponsor to facilitate specimen collection
  • Work with other centers to coordinate ongoing large registries including: enrollment reports, providing query/missing data reports, training other centers on changes to the database
  • Create, update and maintain IRB applications (amendments, ORIOs, AEs)
  • Manage and maintain compliance with regulatory requirements and study protocols
  • Provide oversight of data collection to ensure compliance with protocol and data protection
  • Directly report any issues to the Principal Investigator and/or Program Manager and implement necessary actions to reconcile the issue 
  • Meet and work with sponsor study monitors 
  • Address and respond in a timely manner to sponsor queries, database completion and regulatory issues Team Supervision
  • Other duties as assigned by PI

Required Qualifications*

  • Bachelor’s Degree
  • Familiarity with RedCap and database building is desired
  • Preferably at least three years of human subject research experience at U-M
  • Preferably at least one-year experience with IRB initial application submissions and amendments at U-M
  • Knowledge of Good Clinical Practice and ICH regulatory guideline
  • Proficiency with Microsoft Office programs including PowerPoint and Excel
  • Demonstrated coordination, time management, communication skills and ability to work independently and as a team member
  • Demonstrated ability to build and maintain relationships with research teams including Principal Investigators
  • Ability to manage multiple priorities with proficiency

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.