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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

Background:

The Medical School Office of Research, in partnership with the Medical Directors of the Neurosciences and Sensory Clinical Trials Support Unit (CTSU), is seeking an experienced administrator with a demonstrated strong leadership and change management track record to lead the administrative, operational, and managerial functions of the Neurosciences and Sensory CTSU

Function and Responsibility:

The Clinical Trial Support Unit Lead Administrator is an experienced manager and clinical research administrator, who serve 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 Director, 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 the CTSU, including, but not limited to (i) supervising staff, such as financial specialists, clinical research project coordinators/managers, research coordinators, regulatory staff, administrative assistants, and other staff participating in 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 Director to take appropriate corrective actions when necessary. The Administrator will work in close partnership and collaboration with other clinical trial support unit lead 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 Director(s) of the CTSU and administratively to the Medical School Office of Research Clinical Trials Support Office, Director of Clinical Trial Operations.

Responsibilities*

  • Collaborates closely with the Medical Director of the CTSU, participating departments, and the Medical School to refine and implement a strategic vision and plan for the CTSU.
  • Interfaces with clinical trials staff of participating departments (currently Neurology, Dermatology and Neurosurgery) and with clinical trials staff of individual investigators
  • 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 Director, CTSU Staff, and 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.
  • Provides 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 break-even analysis
    • Negotiating with industry sponsors
    • Developing corrective action plans when necessary
  • Works closely with study teams to ensure timely feasibility review and approval for all new protocol applications to the CTSU.
  • Oversees activities of CTSU specific staff and interfacing with departmental clinical trials staff monitoring the life-cycle 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.
    • 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.

Required Qualifications*

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. 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. Strong integrity, professionalism and discretion. Superior customer service orientation.

Desired Qualifications*

Familiarity with human subjects research and the conduct of clinical trials strongly preferred.  Excellent working knowledge of federal, state, and institutional regulations, policies, and procedures is desirable.

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

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.

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.

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.