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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

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*

Lead and manage clinical research activities/data management in NCTN assigned programs

  • Functional supervision of clinical research/subjects coordinators (CRC):
    • Oversee and assist with the quality of clinical trial coordination/data collection and management.
    • Train and educate clinical research coordinators on aspects of clinical research.
    • Assess workload and assist staff in distribution of studies amongst CRCs as needed.
    • Facilitate resolution of study related data issues.
    • Maintain data coverage including fielding and approving time off requests.
    • Provide administrative support including effort estimates, study startup, and CRT oversight. Create protocol folder, CRT intake forms, enter into OnCore, complexity score review and request feasibility review add to tracking sheet. Send documents to regulatory staff to start e-research application and finance to complete billing calendar.
    • Provide feedback to O-CTSU leadership on team performance.
    • Provide and manage Data/Query report review and distribute to staff on monthly basis.
    • Perform in house 6 month interim audits for quality assessment, reviewing patient charts and regulatory.
    • Responsible for 3 year and other NCTN audits - prepare CAPA reports, work with IDS, request EMR access, review audit charts.
    • Perform 1-1 weekly meetings with staff and lead Monthly LAPS team meetings.
    • Participate in LAPS Leadership meetings with grant PI and designated co-investigators.
    • Participate in LAPS meeting with Grant PI monthly to discuss staffing updates, data, any general concerns, review open and closed trials.
    • Assist PI on new grant application/renewal as required to provide references to write Grant report for the NCI- (audit reviews, biography's from investigators, New staff, publications, accrual reports etc.).
    • Support submission of yearly grant reports (RPPR) to the NCI.
    • Administrative supervision of Clinical research coordinators as appropriate.
    • CIRB Administrative support for NCTN members (access to trials, roles, Delegation of Log duties).
    • Interact with Affiliates (Mid Michigan, Ann Arbor VA).
    • Attend NCTN group meetings as appropriate (SWOG, ECOG/ACRIN, ALLIANCE and NRG).
    • Manage UPS accounts for New Staff.
    • Oversee team compliance with OnCore Calendar completion.
    • Work closely with staff to ensure study compliance and assists in the analysis of data.
    • Assist staff with meeting requirements for appropriately reporting study deviations, adverse events, serious adverse events and preparation of Data Safety and Monitoring reports. Insures compliance with SPGs, GCPs, FDA, ICH and IRB regulations/guidelines/policies.

Serve as a leader for NCTN/LAPs activities within the O-CTSU

  • Interface with clinical research programs, oversee research activities such as feasibility meetings, pre-SIV, logistic meetings, SIV meetings, department meetings, and CRT meetings as needed.
  • Manage CIRB activities for investigators
  • Supervise team including hiring and training staff and ongoing performance management such as annual reviews and disciplinary action.
  • New investigator applications for NCTN Group membership (request letter of recommendation, confirm CTEP ID, link them to the CTSU RUMS system).

Serve as a data and regulatory study coordinator on program studies ?

  • Provide data management and study coordination on multiple projects that support faculty members and the research team in the conduct of clinical research projects.
  • Enter required data in CTMS in a timely fashion to meet department needs.
  • Work closely with staff to ensure study compliance and assists in the analysis of data.
  • Register eligible patients to CTMS and with Sponsor after confirmation of eligibility.
  • Accurately and precisely abstract data on patients from various sources to comply with requirements of sponsor and protocol.

Required Qualifications*

  • Bachelor’s degree with demonstrated commitment to continued professional development
  • 2+ years Oncology research experience
  • 4+ years Clinical research experience
  • ACRP, SoCRA Certification
  • Demonstrated high level of competency in roles that will fall under CRPM title
  • Demonstrated emphasis on teamwork
  • Excellent interpersonal and conflict resolution skills, diplomacy
  • Fully engage in and actively contributing to team/O-CTSU/Cancer Center mission and vision
  • Takes initiative in process improvement and functions in self-directed manner

Desired Qualifications*

  • 1+ years supervisory experience

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. 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.