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 essential regulatory documentation is collected, maintained, and filed in the Trial Master File
• Facilitate IRB, Sponsor-Investigator, and site interactions to support regulatory compliance
• Screen adverse events for seriousness and coordinate AE/SAE reporting to sponsors and IRBs
• Support adherence to local, federal, and institutional research regulations

Study operations and participant management
 

• Monitor participant recruitment, enrollment, and retention; collaborate with teams to enhance recruitment strategies
•  Assist in maintaining accurate study databases (enrollment, refusals, deviations, withdrawals)
•  Support timely and complete study documentation to ensure efficient trial operations

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
• Maintain and develop best practices and standards for efficient monitoring and quality oversight

• Bachelor's degree with at least 2 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 the ability to effectively problem-solve and implement solutions to improve processes
• Excellent interpersonal and conflict resolution skills

• SOCRA or ACRP certification 
• Work experience in monitoring clinical trials in an academic or industry setting, including monitoring compliance with research regulations
   

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.

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.

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

Clinical Research Coordinator Associate: $52,797-$65,220

The University of Michigan is an equal employment opportunity employer.