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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 position.

Job Summary

Function in a remote office capacity (geographical location anywhere in the contiguous United States is acceptable).This position will serve as a Clinical Research Project Manager in the Oncology Clinical Trial Support Unit (O-CTSU) providing project management, regulatory and data management oversight and clincal monitoring 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.

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
  • 2:1 Match on retirement savings.

Responsibilities*

This position will provide project management, regulatory and data management oversight and clinical monitoring support for multi-site trials coordinated by the Oncology Clinical Trials Support Unit (CTSU) from trial start-up through trial closeout. The incumbent will act as a liaison between the clinical sites, the CTSU and sponsors/agencies/cooperative groups to ensure that clinical trials are conducted in compliance with the protocol, and applicable institutional and regulatory guidelines.

Develop and maintain study manual of operations, and standard data collection procedures, Monitoring Plan and other study documents. Maintain master trial files and manages the study progress in relation to the project timelines. Assure that the clinical sites are enrolling subjects, collecting data, and conducting the trial in compliance with approved protocol version, GCP and ICH guidelines and verify patient eligibility. Prepare clinical sites for study start-up by reviewing and tracking regulatory documents, ordering start-up supplies and conducting site initiation visits.

Conduct ongoing site monitoring visits. Monitor adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported to the study supporter and all participating site IRBs. Oversees the maintenance and organization of project documentation and records. Act as a liaison between the clinical site(s) and the data coordinating center to resolve any issues that may arise throughout the course of the study.

Other responsibilities may include but are not limited to; updating and revision of SPGs, training and orientation of study staff, organization of coordinator/investigator meetings. Participate in group and department initiatives. Perform other duties as assigned by management.  This position has the opportunity to function in a fully remote capacity.

Required Qualifications*

  • Bachelor’s degree or higher in health science or health-related field
  • Strong background and/or experience in clinical research site management, regulatory management and data management
  • Excellent written and verbal communication skills
  • Strong organizational skills with ability to multi-task and prioritize
  • Must have exceptional attention to detail and understanding of compliance issues with regard to human subject research
  • Outstanding teamwork and customer service orientation
  • Ideal candidate will have strong knowledge of 45 CFR part 46 and 21 CFR parts 50
  • Willingness to travel up to 30% for monitoring trips.

Desired Qualifications*

  • Two to five years’ previous experience in the conduct of clinical trials is desired
  • SoCRA or ACRP certification, preferred

Work Locations

O-CTSU Administration is located at NCRC in Ann Arbor, MI. However, this position has the opportunity to function in a fully remote capacity.

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.

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.

 

U-M COVID-19 Vaccination Policy

COVID-19 vaccinations are now required for all University of Michigan students, faculty and staff across all three campuses, including Michigan Medicine.  This includes those working or learning remotely.  More information on this policy is available on the Campus Blueprint website or the U-M Dearborn and U-M Flint websites.