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.

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.

• 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

• 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

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

This is a 5-year term-limited position, with possibility of renewal contingent on funding availability.

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.

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.

• 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

• 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

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

This is a 5-year term-limited position, with possibility of renewal contingent on funding availability.