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 CTSU Lead Administrator, this position is responsible for developing, enhancing and managing the clinical trials serviced by the CTSU. Organize the day-to-day research and protocol specific activities associated with the CTSUs’ portfolios as it pertains to participation in clinical trials. Participate in assessing the feasibility of new studies. Work with the CTSU Medical Directors and Lead Administrator to ensure appropriate monitoring of individual studies and all CTSU clinical trials in aggregate. Ensure that new studies are initiated appropriately and monitor the performance and progress of ongoing studies. Work closely with the CTSU finance and coordinator teams. Coordinate with other CTSUs as appropriate. Coordinate with ancillary units as appropriate (i.e. IDS, MCRU).
Manage the day-to-day work flow of clinical trials (in aggregate).
Monitor the status of start-up timelines for new studies, as well as progress of ongoing studies.
Serve as initial point of contact for new clinical trials coming to the CTSU.
Respond to and log all new project intake forms.
Process unfunded agreements (UFAs) in eResearch Proposal Management System.
Correspond with sponsors to obtain trial information and required documents (protocol, draft agreement and draft contract).
Participate in the feasibility review for new studies including staffing and budgetary requirements, clinical and logistical considerations, and competing studies.
Keep abreast of IRB application and contract execution progress.
Participate in billing grid/calendar review and update.
Facilitate efforts to address issues.
Serve as an expert resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem solving related to clinical, logistical, financial and regulatory issues.
Assist PIs, study coordinators and research staff in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.
Read and understand work guides to ensure CTSO standard processes are followed.
Ensure task lists stay up-to-date.
Prepare weekly summary information for review by the team.
Stay constantly aware of where all projects are in the pipeline.
Continually look for opportunities to gain efficiencies.
Run reports to stay informed of subject enrollment and visits completed.
Schedule planning and other meetings for the CTSUs.
Assist in the production and review of key metrics.
Manage mail groups for the dissemination of information.
Study coordination or regulatory activities may be assigned as needed.
Other duties and responsibilities as assigned.
Master’s Degree or equivalent preferred. Mastery of previous positions required. Ability to work independently or in a team environment. Clinical coordination or related clinical research experience required. Solid understanding of the study team role in opening and managing clinical trials. Positive attitude and strong customer service focus. Must be willing to lend a hand when needed.
ACRP or SoCRA Certification.
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
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.