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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.

Job Summary

Collects and manages patient and laboratory data for clinical research projects. Screens and has oversight for the recruitment of subjects, supervises the scheduling of experiments and the collection, processing and analysis of data. Collects specimens and monitors subjects. Assists in the reporting of test results. Employees in this classification typically analyze, compare and evaluate various courses of action and have the authority to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities. Primary activities and decision making authority are predominantly performed independently affecting business operations to a substantial degree. 

Responsibilities*

• Assist with the recruitment and retention of subjects, scheduling of procedures, and collection of data.

• Maintains accurate research records and transcribes collected data onto source documents and electronic case report forms.

• Assist with identification and documentation of adverse events according to standard operating procedures and protocol requirements.

• Assists with writing, editing, and renewing Institutional Review Board applications, and billing calendars.

• Assures compliance with protocols, adherence to good clinical practice guidelines, FDA regulations, and all other federal, local, and University guidelines.

• Perform study-specific tests in clinic such as mini-mental, grip test, and walk test.

• Other duties as assigned or required for the research project.

• Some weekend coverage hours are anticipated during study enrollment period.

• Some overnight travel expected for study related meetings and conferences.

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

Supervision Received:

Functional supervision is received from the principal investigators, co-investigators, and project manager(s). This position will work in collaboration with the project manager(s) and other team members. Administrative supervision is received from the Chief Department Administrator of Cardiac Surgery and the Director of Cardiovascular Medicine.

Supervision Exercised:

None

Required Qualifications*

  • Bachelor’s degree in a science or health-related field and two or more years of experience in the conduct of human subjects research, or equivalent education and experience.
  • Certification through ACRP or SOCRA or willingness to become certified.
  • Demonstrated knowledge of medical and research terminology and familiarity in aortic disease and its pathway.
  • Ability to work with minimal supervision with diverse teams of people in a diplomatic, collaborative and effective manner.
  • Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
  • Exceptional organizational and computer skills are required with proficiency in Microsoft software applications.
  • Demonstrated problem solving and conflict resolution skills.
  • Ability to multi-task, work well under time constraints and meet deadlines.
  • Demonstration of commitment to FCVC Core Values.

Desired Qualifications*

  • Previous experience with coordination and management of device trials (IDE and HDE) desired.
  • Demonstrated understanding of GCP, ICH, and FDA regulations.
  • Prior experience with Bioresearch Monitoring Program (BIMO) audits including preparatory quality assurance reviews.

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 any time after the minimum posting period has ended.

U-M EEO/AA Statement

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