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.
As part of the strategic research initiative, the Clinical Trials Support Office is now overseeing a new model to improve clinical care, value, and health outcomes by successfully executing a diverse portfolio of high-quality clinical trials. This new model entails an organizational structure of local service units, central infrastructure, and governance oversight. The Clinical Trials Support Units (CTSUs) are trans-departmental and thematically aligned based on research foci. CTSUs are the local units that provide comprehensive pre- and post-award, and study coordination support to study teams, offering high-quality, efficient service in support of a mix of clinical trials. They provide a professional environment of expert personnel accessible to all investigators, especially early-career faculty.
In collaboration with the Oncology CTSU (O-CTSU) Lead Administrator, this position is responsible for developing, enhancing and managing a portfolio of multi-institutional, investigator-initiated clinical trials serviced by the O-CTSU as the coordination center. This position oversees a team of 10 staff supporting a growing portfolio of 30 active trials, 100+ participating sites with $40M in research funding. For the Rogel Cancer Center, this position is a leading voice in multi-intuitional operations both locally and among our national peer institutions.
Leadership (50%): Leads the successful execution of Oncology clinical research by establishing professional relationship with research investigators, research and clinical staff, sponsors, pharmacists and all personnel involved in the conduct of clinical research. Assures dissemination of information to enhance collaboration through all phases of the research process from feasibility of new studies thru termination. Provides oversight and follows Good Clinical Practice (GCP) for clinical research. Guides studies through their lifecycle with particular attention during study activation.
Management (30%): Interviews, hires, fires, recommends promotions, adjusts rates of pay, establishes work hours, oversee training, mentoring, and supervision of the team-specific research personnel in the O-CTSU. Build project management & monitoring teams based on study complexity, accrual goals, staff training and experience, and workload equity. Ensures team compliance with departmental policies, systems (CTMS, EDC, Effort Tracking, etc.) and study monitoring plans. Handles complaints, grievances, and disciplinary actions when necessary. Develops and fosters relationships with study team members at participating sites, departmental units and other institutional partners (IRB, ORSP, etc.)
Financial/Other (20%): Demonstrates fiscal responsibility for team’s impact on the department budget by developing effort estimates, controlling costs, and improving efficiencies. Provides ongoing review of variances in budgeted effort and actual effort and the impact on study account health; initiates change in study budgets, team cost, and efficiency as needed. Ensures proper and timely use of clinical trials management systems to facilitate patient and staff effort billing. Reviews and utilizes effort tracking reports to ensure staff remain within 95% compliance goal with effort tracker. Coordinate with other CTSUs as appropriate. All other assigned job duties and responsibilities.
Bachelor’s degree in an appropriate field; Strong interpersonal, analytical and communication skills. Ability to effectively lead work teams. Demonstrated history of excellent management skills. 5+ years of experience in clinical research with multi-institutional trials.
Master’s Degree or equivalent. 2+ years previous supervisory experience, preferably in clinical trials research setting. Certifications: Association of Clinical Research Professionals (ACRP), Society of Clinical Research Associates (SoCRA), Certified IRB Professional (CIP), Regulatory Affairs Certificate (RAC) and/or Project Management Professional (PMP).
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks are performed in compliance with the Fair Credit Reporting Act.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 173697
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.