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.
The Medical School Office of Research, in partnership with the Medical Directors of the Ambulatory Chronic Disease (ACD) Clinical Trials Support Unit (CTSU), is seeking an experienced clinical research administrator with a demonstrated ability to lead the operational and managerial functions for this CTSU. As part of a strategic research initiative we have engaged the entire University of Michigan Health System (UMHS) to create a model aimed at improving clinical care, value, and health outcomes by implementing a diverse portfolio of high-quality clinical trials.
This model entails an organizational structure of local support units, central infrastructure, and governance oversight. The CTSU’s, which are trans-departmental and thematically aligned based on research foci, represent the local support units and offer comprehensive pre- and post-award support, professional support staff, and additional operational assistance to study teams. The Medical School Office of Research is responsible for the central infrastructure, providing enterprise-wide standards, policies, and common support needs that can be leveraged by the CTSU’s and study teams. The entire system is governed by the Medical School Office of Research in partnership with the Clinical Trials Subcommittee (CTSC) of the Research Board of Directors (RBOD).
The ACD CTSU Lead Administrator is an experienced manager and clinical research administrator, who serves as the senior administrative lead for clinical trials infrastructure operations and development within the CTSU. The Administrator will work in close partnership with the Medical Directors, Medical School Office of Research, and Clinical Trial Subcommittee to develop and implement the clinical trials infrastructure for the CTSU. The Administrator is directly responsible for the day-to-day management of all staff and operations related to their CTSU, including, but not limited to (i) supervising staff, such as financial analysts, project coordinators/managers, research coordinators, and other staff associated with the CTSU; (ii) implementing central policies and procedures; (iii) developing, negotiating, and monitoring trial budgets; (iv) administration of the protocol feasibility process; (v) responsible for the fiscal management of the CTSU operations, including budgeting, reconciling, and reporting of CTSU finances to the Medical Director, Advisory Board, and Clinical Trial Subcommittee/Research Board of Directors; and (vi) tracking, reviewing and interpreting evaluative metrics along with the Medical Directors to take appropriate corrective actions when necessary. The Administrator will work in close partnership and collaboration with other CTSU administrators to ensure strong coordination and open communication across the CTSU’s, especially regarding sharing of best practices and lessons learned as well as developing consensus on common approaches to change management, continuous improvement, and prioritizing faculty and CTSU needs. The Administrator will act as a spokesperson and advocate for the CTSU within and outside the University and is responsible for outreach, communications, and public relationships activities, such as planning and implementation of networking and outreach events.
The Administrator reports functionally to the Medical Directors of the CTSU and administratively to the Director of the Clinical trials Support Office in the Medical School.
- Collaborates closely with the Medical Directors of the CTSU, participating departments, and the Medical School to refine and implement a strategic vision and plan for the CTSU.
- Supports the Medical Director in working with the RBOD, CTSC, Medical School Office of Research, and the CTSU Advisory Board comprised of Department Chairs, or their designees.
- Creates operational systems, programs, and infrastructure necessary to support and accelerate output from Medical Directors, CTSU Staff, and principal investigators (PIs) affiliated with the CTSU.
- Provides leadership in developing, implementing, and managing all administrative, business, and programmatic functions of the CTSU. Examples of responsibilities include, but are not limited to, sound financial management (budget preparation and management); human resource management of staff; operational and administrative management; and designing business plans, as needed, to cost-effectively sustain the infrastructure and offerings of the CTSU.
- Supports development of CTSU research communities.
- Collaborates with the other CTSU Administrative Leads to share efficiencies, optimize processes across CTSU’s, and standardize common procedures.
- Provide a culture and environment of superior customer service delivery.
- Optimizes the operational functions of the CTSU by developing systems for the integration of metrics to improve business practices.
- Oversees development of proposals and protocols to improve application success and ensure feasibility. This may include:
- Working closely with Medical Director, CTSU Staff, and PI to ensure studies do not conflict.
- Conducting breakeven analysis.
- Negotiating with industry sponsors.
- Works closely with study teams to ensure timely feasibility review and approval for all new protocol applications to the CTSU.
- Oversees activities of the staff monitoring the lifecycle maintenance of protocols, including but not limited to activities related to:
- Ensuring short code and billing code creation.
- Verifying IRB approval.
- Preparation of billing calendars.
- Oversight of sponsor billing.
- Oversight of fiscal status of protocols.
- Receive status reports from study monitors.
- Project and grant extension requests and closeout.
- Serves as an advocate for the clinical trial investigators and CTSU staff. Provides support for staff in the daily work of maintaining clinical trials research infrastructure.
- Serves as a spokesperson and liaison for the CTSU and clinical trials research within the University community and with external partners
- Works with the medical directors, administrative team and research infrastructure to ensure the CTSU is a welcoming and productive home for members to pursue novel interdisciplinary research and innovation.
- Supports implementation of central policies and procedures related to clinical trial management including knowledge of process and procedure to approve proposals (PAF routing), communications, and financial management.
Requires educational experience generally associated with at least a Bachelors degree (or higher) and five or more years of progressively responsible experience in the conduct and/or supervision of clinical research, research infrastructure development, business operations, and/or healthcare administration. Significant managerial and supervisory experience with proven track record in business operations and systems/process improvement required. Familiarity with human subjects research and the conduct of clinical trials strongly preferred. Ability to work effectively in a large academic organization with a diverse and broad group of clinical research partners and stakeholders. Reasonable knowledge of information systems, networks, and data processing/reporting functions is necessary. Must have strong organizational, analytical, customer service, and leadership skills. Must have demonstrated ability to effectively communicate, both orally and in writing, and persuasively present unit and institutional positions to build consensus to achieve goals and objectives. Excellent working knowledge of federal, state, and institutional regulations, policies, and procedures is desirable. Strong integrity, professionalism and discretion. Superior customer service orientation.
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.
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.