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 address your specific interest in the position and outline your experience that directly relates to this position.
Job Summary
Being part of something greater, of serving a larger mission of discovery and care, that's the heart of what drives people to work at Michigan. In some way, great or small, every person here helps to advance this world-class institution. It's adding a purpose to your profession. Work at Michigan and become a victor for the greater good.
The Statistical Analysis of Biomedical and Educational Research (SABER) unit is the data coordinating center for several multi-center clinical trials and observational studies. We are a research center located within the Biostatistics Department at the School of Public Health (SPH) on Michigan's central campus. SABER clinical study monitors provide independent oversight of study conduct and collaborate with project managers, principal investigators, and coordinating center leadership to ensure compliance and alignment across study activities. We work with clinical sites to move the project forward according to Good Clinical Practice (GCP) guidelines. We are looking for an experienced and dynamic staff member to contribute positively to our community.
SABER prides itself on fostering a collegial, open, and family-friendly work environment, and our team is fully remote.
For more information on SABER, please visit: https://sph.umich.edu/saber/index.html.
For more information on the Biostatistics Department, please visit: https://sph.umich.edu/biostat/index.html.
Responsibilities*
Project Coordination and Stakeholder Communication
- Serve as the primary project manager for assigned studies, providing overall coordination and operational oversight.
- Lead study meetings, including development of agendas, documentation of meeting minutes, tracking of action items, and follow-up on key decisions.
- Maintain study timelines, milestones, risk logs, and issue trackers to support successful study execution.
- Facilitate communication and collaboration among DCC functional teams, clinical sites, investigators, study leadership, monitors, vendors, and external stakeholders.
- Provide regular study status updates and escalate operational risks or issues as appropriate.
Study Operations and Site Management
- Support study startup, conduct, and close-out operational activities.
- Develop, maintain, and distribute study-specific operational documents, templates, manuals, and guidance materials.
- Coordinate site startup activities, including training and study activation activities.
- Track study enrollment, site performance, operational milestones, and study deliverables.
- Collaborate with study teams to identify and resolve operational challenges affecting study conduct.
Data Quality, Monitoring, and Data Management Support
- Collaborate with data management teams on electronic case report form (eCRF) design, database testing, validation, and implementation activities.
- Assist with clinical monitoring activities.
- Review data quality metrics and reports to identify trends, discrepancies, and potential data issues.
- Coordinate data query management activities and facilitate timely resolution of data discrepancies with study sites.
Regulatory, Safety, and Compliance Support
- Coordinate adverse event (AE) and serious adverse event (SAE) reporting and tracking activities in accordance with study and regulatory requirements.
- Coordinate Data and Safety Monitoring Board (DSMB) activities, including meeting logistics, preparation of DSMB reports, safety summaries, and study progress reports, as well as documentation and follow-up on DSMB recommendations and action items.
- Help to ensure study documentation remains complete and inspection-ready.
- Monitor compliance with study protocols, monitoring plans, Good Clinical Practice (GCP) requirements, institutional policies, and applicable federal regulations.
Required Qualifications*
- SOCRA or ARCP certified, or obtained within 2 years of hire
- Bachelor's degree with at least 5 years of experience, or an equivalent combination of education and work experience in a research setting
- Implementation of GCP, ICH guidelines, and applicable regulatory guidelines in the conduct of clinical research
- Experience in reading medical records
- Proficient in electronic data capture systems, e.g., OpenClinica, REDCap Cloud
- Ability to communicate effectively and follow written and verbal instructions
- Demonstrate strong analytical and organizational skills, including high level accuracy and attention to detail while exercising good judgment
- Proven ability to set priorities, exercise initiative, work simultaneously on numerous projects and meet/negotiate deadlines
- Ability to effectively work independently, as well as with diverse teams
- Demonstrate efficient organizational skills and ability to effectively problem solve and implement solutions to improve processes
- Excellent interpersonal and conflict resolution skills
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 Locations
This is primarily a remote work position. Pending travel restrictions, you may be required to travel within the United States (and possibly internationally) up to 25% to participate in clinical sites and investigator meetings.
Underfill Statement
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
Additional Information
This is a 5-year term-limited position, with possibility of renewal contingent on funding availability.
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.