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 Clinical Trials Support Office (CTSO) is part of Michigan Medicine’s strategic research initiative working towards improving clinical care, value, and health outcomes by successfully executing a diverse portfolio of high-quality clinical research. The CTSO provides the organizational structure of local service units, central infrastructure, and governance oversight. Within the CTSO, Clinical Trials Support Units (CTSUs) aligned by research foci, are trans-departmental and provide comprehensive pre- and post-award support to study teams, offering high-quality, efficient service in support of a wide variety of clinical research.
The CTSO helps life-changing research happen. The science we support is not only interesting, but it also has the very real potential to positively impact patients and their families. We are looking for a candidate who embraces their supporting role in pushing these scientific advancements forward. If you are a study coordinator looking to take your career to the next level, this position is for you. The CTSO is a relatively new organizational model. You’ll have the flexibility to impact the entire team as our unit expands its mission to support clinical research. Creative problem-solving skills are strongly encouraged.
In collaboration with the CTSU Medical Directors and Lead CTSU Administrators, the Portfolio Manager is responsible for developing, enhancing and managing the clinical trials serviced by the CTSU. This position will supervise the day-to-day research and protocol specific activities associated with the CTSU as it pertains to participation in clinical research studies.
Manage the assigned portfolio of clinical trials (in aggregate) related to study activation, conduct and closeout. Responsibilities include, but are not limited to:
Along with the Lead Administrators serve as an initial point of contact for new studies;
Process intake forms and unfunded agreements;
Correspond with sponsors to obtain trial information and required documents to initiate the activation process;
Monitor the status of start-up timelines for new studies including IRB approval and contract execution;
Coordinate with other CTSUs and ancillary units as appropriate (i.e. ORSP, CRAO, IDS, MCRU);
Along with the Lead Administrators and the Medical Directors participate in the CTSU feasibility review for new studies including staffing and budgetary requirements, clinical and logistical considerations, and competing studies;
Facilitate billing calendar review and updates;
Lead study planning meetings and facilitate connections with strategic partners and resources as applicable;
Monitor the progress of ongoing studies including enrollment;
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.
Manage mail groups for the dissemination of information.
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. 5 or more years’ clinical research experience at a progressively involved level.
ACRP or SoCRA Certification desirable.
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. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
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. 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: 182743
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.