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How to Apply

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.

Responsibilities*

  • Collect and manage patient and laboratory data for clinical research projects
  • Screen and have oversight for the recruitment of subjects per study protocol
  • Supervise the scheduling and the collection and processing of data
  • Collect specimens, monitor subjects and ensure patient’s response to therapy is adequate to continue on study
  • Coordinate the handling of study medications
  • Assist in the reporting of test results
  • Design work flow and participate in quality assurance measures and coordinate study site visits
  • Prepare appropriate reports on each research patient, maintaining and completing the supplied case report forms for investigator and/or sponsor
  • Facilitate audits from sponsor institutions or internally
  • Participate in conferences related to the project and/or its progress
  • Coordinate communication between team members re: opening/closing of protocols, new information/amendments and administrative requests from study sponsors
  • Assist in submitting new protocols, applications and consents, amendments, adverse event reports, renewals, etc
  • Complete Institutional Review Board (IRB) applications
  • Edit and renew IRB applications
  • Create amendments as required per protocol
  • Correspond with IRB and other core committee staff
  • Generate IRB approved consent forms
  • Submit Data Safety reports to the Data Safety Management Board and IRB
  • Build and maintain regulatory binders for each study
  • Other duties as required and determined by study PI

Required Qualifications*

  • Bachelor’s Degree
  • 3-5 years of clinical research experience
  • Excellent interpersonal and organizational skills
  • Ability to organize/prioritize tasks effectively and efficiently
  • Ability to set goals, promote teamwork and problem solve
  • Excellent computer skills

Desired Qualifications*

  • Experience with multi-institutional protocols
  • Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) Certification (required within 2 years of DOH)
  • Some IRB/regulatory experience
  • Experience with the University of Michigan’s eResearch system
  • Oncology experience
  • Reasonable knowledge of University research policies, procedures and computer systems

Evidence of qualifications is provided by previous employment, references and performance evaluations

 

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.

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.