Clinical Study Monitor

Clinical Study Monitor University of Michigan - 4.3 Ann Arbor, MI Job Details Full-time $69,639 - $86,025 a year 1 day ago Qualifications Clinical research Data analysis skills Improving operational efficiency ICH guidelines Conflict management Research regulatory compliance Healthcare compliance Full Job Description 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. 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• Clinical monitoring and site oversight Conduct on-site and remote monitoring visits to assess compliance with GCP, ICH, protocol requirements, and regulatory standards Perform source data verification and review CRFs for accuracy, completeness, and timeliness Prepare detailed monitoring visit reports documenting site, pharmacy, laboratory, and unit performance Reconcile investigational product/device accountability with clinical sites Regulatory compliance and safety oversight Ensure Trial Master File (TMF) completeness, quality, and inspection readiness, ensuring alignment with regulatory expectations and audit standards Serve as a subject matter expert on regulatory compliance, advising study teams and leadership on FDA regulations, GCP, and evolving guidance Oversee safety surveillance processes, including review and escalation of AE/SAE reporting, ensuring compliance with reporting requirements and timelines Apply prior FDA auditing experience to assess compliance gaps, conduct internal audit readiness activities, and guide teams in remediating findings and preventing recurrence Study operations and participant management Provide strategic oversight of site performance, including enrollment, retention, and protocol adherence, and partner with stakeholders to implement data-driven improvement plans Evaluate study-level operational metrics and trends (e.g., deviations, enrollment barriers), and recommend corrective and preventive actions to optimize trial execution Ensure end-to-end operational excellence by establishing expectations for high-quality, contemporaneous documentation and efficient study workflows Cross-functional collaboration and continuous improvement Partner with project management, data management, statistics, regulatory, and quality teams to identify issues and implement solutions Consult across SABER functional areas to support successful study conduct Participate in internal and external meetings and contribute to departmental policy review Drive continuous improvement initiatives by developing and refining monitoring strategies, SOPs, and best practices, incorporating audit insights and regulatory trends Required Qualifications• SOCRA or ARCP certified, or obtained within 2 years of hire Bachelor's degree with at least 10 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 Work experience in monitoring clinical trials in an academic or industry setting, including monitoring compliance with research regulations and supporting or participating in FDA inspections and audits (desired) 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 the 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 employment opportunity employer. Job Opening

ID 276664

Working Title Clinical Study Monitor Job Title Clinical Research Coord Senior Work Location Ann Arbor Campus Ann Arbor, MI Modes of Work Mobile/Remote Full/Part Time Full-Time Regular/Temporary Regular FLSA Status Exempt Organizational Group School Pub Health Department SABER / Biostatistics Posting Begin/End Date 4/28/2026 - 5/05/2026 Salary $69,639.00 - $86,025.00 Career Interest Research