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.
A new model for the clinical trials enterprise includes an organizational structure of local Clinical Trial Support Units (CTSUs), central infrastructure, and governance oversight. The CTSUs are trans-departmental and thematically aligned based on research foci. CTSUs are the local units that provide comprehensive pre- and post-award support to study teams, offering high-quality, efficient service in support of a mix of clinical trials. They will provide a professional environment of expert personnel accessible to all investigators, especially early-career faculty.
In collaboration with the CTSU Medical Directors and Lead CTSU Administrator, this position is responsible for developing, enhancing and managing the clinical trials serviced by the CTSU. Supervise the day-to-day research and protocol specific activities associated with the CTSU as it pertains to participation in clinical research studies. Supervise study coordinators. Establish training standards and ensure that staff meets those standards. 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. Working with the CTSU business analysts and regulatory specialists coordinate IRB submissions, patient recruitment and enrichment, data collection, safety reporting, drug accountability, and record retention. Coordinate with other CTSUs as appropriate. Coordinate with ancillary units are appropriate (i.e. IDS, MCRU)
Handle pre- and post-award activities ensuring all Medical School, University and sponsor policies and guidelines are followed. Specific pre-award duties include UFA, CTRF, and PAF creation and routing, budget creation and negotiation, and billing calendar preparation. Specific post-award duties include account reconciliation, processing patient reimbursement, invoicing the sponsor, resolving clinical research billing errors, ensuring revenue collection, and handling A21 and Financial Status Reports. Assist in completion of progress and final reports as applicable.
In partnership with the CTSU Administrator, assist in managing the units’ clinical trials financial portfolios. Specific duties may include collecting and maintaining data for metrics; analyzing, forecasting, and reporting (i.e. monthly, annually) on the CTSU’s comprehensive financial portfolios. This position will assist in the preparation and presentation of financial portfolio reports to key stakeholders including the CTSU Advisory Board, Medical Directors, Administrators, and Clinical Trials Subcommittee.
Build and foster relationships with other units, as well as sponsors. Serve as liaison for faculty with sponsor, and University central offices (i.e. Sponsored Programs and ORSP).
Assist in the development and implementation of a plan to bring already existing/ongoing trials into the CTSU. This would require close collaboration with departments, faculty, study teams, research administrators, and others to ensure a smooth transition and completeness of records.
Other duties and special projects as assigned.
- Bachelor’s degree or equivalent experience with 2-5 years of experience specifically in finance, management, business, or a related field.
- Experience with pre- and/or post-award research administration activities, preferably clinical trials.
- Solid understanding of sponsored projects, particularly the aspects of clinical research finances and reporting requirements.
- Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative, and effective manner.
- Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
- Excellent computer skills including proficiency in finance related programs/tools such as Excel, M-Pathways, M-Reports, and the Data Warehouse.
- Ability to manage multiple tasks simultaneously, to work well under time constraints, and meet deadlines, as well as prioritize and exercise good judgment.
- Understanding of some basic medical terminology.
- Demonstrated experience working with a variety of sponsors including industry, federal agencies, cooperative groups, foundations, and gifts.
- Experience with the U-M systems including MBECT and HSIP.
- Knowledge of Medical School and/or University policies and procedures.
- OnCore training.
- Experience in financial management for a small business.
Monday - Friday
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.
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.
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.