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 describe your specific interest in the position and highlight the skills and experience that directly relate to the position.
Job Summary
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. 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.
Like many administrative units across Michigan Medicine, the CTSO is currently operating under a virtual work model for administrative staff. This position would currently be a work-from-home position and is likely to require little in-person activity in the future.
The Portfolio Coordinator is responsible for providing operational and administrative support for clinical trials and clinical research serviced by the Michigan Clinical Trials Support Unit (MCTSU). Under the guidance of MCTSU leadership and the Portfolio Manager team, this position serves as the initial point of contact for new studies and supports other study start-up and ongoing activities.
Responsibilities*
Provide administrative support for day-to-day operations and protocol-specific activities of a portfolio of clinical research studies. Responsibilities include, but are not limited to:
Serve as an initial point of contact for new studies, triaging and directing them to the appropriate team members or resources.
Process intake forms and enter study information into the Clinical Trial Management System (CTMS).
Process unfunded agreements (UFAs) in the eResearch Proposal Management system (eRPM).
Communicate with sponsors and study teams to obtain trial information and required documentation for study start-up.
Facilitate connections with strategic partners and resources as applicable.
Process and maintain user access to CTMS and electronic regulatory binder systems, including access requests for external study monitors.
Review ongoing studies for quality and compliance, including IRB review status, enrollment and subject visit tracking in OnCore, and work with study teams to complete necessary updates.
Coordinate meeting scheduling.
Provide operational and administrative support to the Portfolio Manager team.
Respond to routine questions from Principal Investigators, study coordinators, and other research staff regarding study-specific requirements; escalate complex matters as appropriate.
Serve as a resource for CTMS and MiChart workflows related to clinical research.
Perform other duties and responsibilities as assigned.
Required Qualifications*
Bachelor?s degree, or equivalent education and experience.
Ability to work effectively both independently and collaboratively in a team environment.
Strong organizational skills, attention to detail, and the ability to manage multiple priorities and meet deadlines.
Strong communication skills, a professional attitude, and a customer service orientation.
Desired Qualifications*
Knowledge of Michigan Medicine research practices, systems, and processes.
At least one year of directly related experience in clinical research or clinical trials.
Working knowledge of study team roles and processes involved in opening and maintaining clinical research studies.
Modes of Work
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.
Work Schedule
Monday to Friday. Like many administrative units across Michigan Medicine, the CTSO is currently operating under a mobile work model for administrative staff. This position would currently be a work-from-home position and is likely to require little in-person activity in the future.
Additional Information
Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.
Background Screening
The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third-party administrator to conduct background checks. Background checks are performed in compliance with the Fair Credit Reporting Act.
Application Deadline
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 any time after the minimum posting period has ended.
U-M EEO Statement
The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.