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Research Compliance Spec Inter

Company: University Of Michigan
Location: Ann Arbor
Posted on: May 3, 2021

Job Description:

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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

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.

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.

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

Responsibilities*

  • Primary responsibilities include completing and submitting electronic Institutional Review Board (IRB) research applications to ensure compliance with University and Federal Government Regulations.
  • 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.

Required Qualifications*

  • 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 clinical research.
  • 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.

Desired Qualifications*

  • 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 desirable.

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.

Job Detail

  • Job Opening ID

196720

  • Working Title

Research Compliance Spec Inter

  • Job Title

Research Compliance Spec Inter

  • Work Location

Ann Arbor Campus

Ann Arbor, MI

  • Full/Part Time

Full-Time

  • Regular/Temporary

Regular

  • FLSA Status

Exempt

  • Organizational Group

Medical School

  • Department

MM O-CTSU Study CoordMulti

  • Posting Begin/End Date

4/16/2021 - 5/04/2021

  • Paid Time Off

Yes

  • Career Interest

Research

Apply Now

Keywords: University Of Michigan, Ann Arbor , Research Compliance Spec Inter, Other , Ann Arbor, Michigan

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