Junior Associate Regulatory Analyst

Michigan, United States
16 Jan 2019
End of advertisement period
16 Mar 2019
Contract Type
Full Time

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

The position of Junior Associate Regulatory Analyst I or II (JARA I / JARA II) is responsible for assisting the research community in reviews of human subjects research applications submitted to IRBMED through a variety of tasks. Applicants for this position are expected to have experience with the conduct of clinical research.

  • Individuals qualifying for the JARA I role would function under supervision and mentorship to perform triage of incoming IRB applications, prepare board meeting agendas, produce board outcome letters, perform informed consent version control, and process minor administrative reviews of submissions.  JARA Is assist in board meeting set-up/tear-down, record attendance and votes at board meetings, and file board meeting documentation.
  • Individuals qualifying for the JARA II role would function under mentorship and limited supervision while learning to independently conduct basic, competent regulatory review of minimal risk IRB applications.   Additionally, JARA IIs are responsible for communicating, clarifying and advising research teams on IRB review requests, concerns and outcomes.  The JARA II processes and clears requested changes in eResearch applications and may assist in providing consultation to research teams.
  • JARA I / JARA IIs work in partnership with members of a regulatory team in the IRBMED office to facilitate the conduct of convened board meetings and to assure that documentation of the meeting is complete and ‘regulatorily’ compliant.  As opportunities permit, JARA I/ JARA IIs may participate on committees within the IRBMED office, support special initiatives including procedure/policy development, and assist with IRB educational activities as assigned by the IRBMED Director. 

Required Qualifications*

  • Bachelor’s Degree in a relevant discipline.
  • A clinical research background is required, including a minimum of 0-1 years’ direct experience with IRBs for the JARA I role or 1-3+ years’ direct experience with IRBs for the JARA II role via positions such as a study coordinator, research monitor, or other research regulatory role.
  • Working knowledge of federal human subject protection regulations (45 CFR 46 and FDA 21 CFR 50, 56, 312, 812).
  • Experience with the preparation or review of IRB applications and familiarity with informed consent documents, adverse event reporting and clinical research protocols.
  • Critical thinking skills are required.  A strong and demonstrated background of written and oral communication, organizational, and interpersonal skills are necessary.  Proficient time-management skills are critical along with the ability to prioritize work.
  • Proficient computer and typing skills are required.
  • Strong writing skills are required. 

Desired Qualifications*

Experience with the eResearch Regulatory Management system and the University of Michigan Health System policies and procedures.

Work Locations

NCRC 520 Building, 3rd Floor

Background Screening

University of Michigan Health System 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

The University of Michigan Health System 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 anytime after the minimum posting period has ended.

U-M EEO/AA Statement

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