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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
This position will serve as a Research Compliance Specialist -
Intermediate in the Oncology Clinical Trial Support Unit (O-CTSU)
providing multi-institutional regulatory support to faculty and
research teams for the University of Michigan Rogel Cancer Center -
an NCI-Designated Comprehensive Cancer Center and a member of the
National Comprehensive Cancer Network (NCCN). We are among the
top-ranked national programs in research and patient care with
members holding $120M in annual direct research funding. Our
mission is to reduce the cancer burden and improve cancer outcomes
through research, innovation and transdisciplinary collaboration.
With the Oncology CTSU, you will join a diverse team of 150
clinical research professionals dedicated in moving this mission
forward through cutting-edge early phase trials to
practice-changing phase III. As a team member, we will invest in
your education, training, career development and certification. We
also offer a variety of specialized roles and growth opportunities
to fit your desired career path and goals. People want
MichiganAnswers. Help discover them.
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.
Why Join Michigan Medicine?
Michigan Medicine is one of the largest health care complexes in
the world and has been the site of many groundbreaking medical and
technological advancements since the opening of the U-M Medical
School in 1850. Michigan Medicine is comprised of over 30,000
employees and our vision is to attract, inspire, and develop
outstanding people in medicine, sciences, and healthcare to become
one of the world's most distinguished academic health systems. In
some way, great or small, every person here helps to advance this
world-class institution. Work at Michigan Medicine and become a
victor for the greater good.
What Benefits can you Look Forward to?
- Excellent medical, dental and vision coverage effective on your
very first day
- Retirement Savings Opportunities
- Primary responsibilities include completing and submitting
electronic Institutional Review Board (IRB) research applications
to ensure compliance with University and Federal Government
- Adept skills with electronic document management and electronic
document control are vital to success in this position.
- Responsibilities: Maintain Regulatory Research records for
several assigned oncology clinical trials. Job specific tasks
include maintaining binders that document the history of the study,
writing & revising informed consent documents that are presented to
potential research subjects; processing & submitting protocol
amendments when the study changes; creating SAE spreadsheets;
submitting SAE reports, submitting DSMB reports and scheduled
continuation renewals as well as study termination reports.
- Responsible for filing, procuring signatures from Investigators
and study team members; collecting CV's from Investigators;
obtaining associated paperwork and numeric values such as lab
normals/CLIA; managing files (in hard copy and via spreadsheet) and
maintaining copies of current paperwork such as current IRBMED
rosters; updating regulatory document information (i.e. updating
1572s, financial disclosures, etc.); creating and organizing
information to ensure accurate submissions to obtain IRB approval;
gathering study renewal information from study team; attending
program team meetings and participating as an actively engaged
member of the team.
- This position requires the academic knowledge and Bachelor's
degree with a health science discipline.
- This knowledge base requires supplementation by three or more
years of progressively responsible experience in data management or
regulatory paperwork (non-clinical) aspects of the conduct of
- The ability to work effectively on a team and problem solve
independently is a must.
- Excellent communication, document handling, prioritization and
multitasking skills are vital.
- Working knowledge of Federal regulations in the conduct of
research involving human subjects is required.
- SOCRA or ACRP certification.
- A Master's degree is desired with relevant work experience in
the area of clinical trials or scientific research
support/management. Familiarity with therapeutic cancer clinical
trials is highly desirable.
- Working knowledge of the U of M IRBMED submission systems
(eResearch) is highly desirable.
- Working knowledge of medical terminology is highly
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.
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
Research Compliance Spec Inter
Research Compliance Spec Inter
Ann Arbor Campus
Ann Arbor, MI
MM O-CTSU Study CoordMulti
4/16/2021 - 5/04/2021