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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 skills and experience that directly relate to this position.

Job Summary

The Statistical Analysis of Biomedical and Educational Research (SABER) unit is the Data Coordinating Center for several multi-center clinical trials and observational studies. SABER responsibilities include monitoring the performance of the clinical sites participating in the trials, with respect to both regulatory compliance and data quality. The position requires travel within the United States and possibly internationally to participating clinical sites.   Candidates may expect to travel weekly.  All monitoring visits may involve overnight 1- to 2-night stays.

Responsibilities*

  • Monitor clinical sites for compliance with GCP and ICH guidelines, including completion of regulatory documents and proper completion of case report forms
  • Conduct site monitoring visits and prepare detailed monitoring visit reports documenting site, pharmacy, laboratory or other unit’s performance
  • Facilitate understanding and implementation of good clinical practice and research regulatory issues for investigators and research coordinators, including provision of complete and accurate study data, adherence to local and federal regulations, and adherence with study protocol procedures
  • Facilitate complete and timely trial master file documentation while interacting with the IRB, Sponsor Investigator and sites
  • Ensure essential regulatory documentation is collected and maintained
  • Perform remote source data verification of CRF critical data elements
  • Reconcile study drug with site reporting
  • Screen all adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reporting to the study sponsor and all participating site IRBs
  • Consult and troubleshoot issues with data management
  • Develop, procure and update materials needed for research project in collaboration with sites
  • Assist in reporting and coordination with site staff to maintain appropriate databases on subject recruitment, enrollment, refusals, protocol deviations and withdrawals
  • Monitor recruitment of subjects and work with team to enhance recruitment
  • Maintenance and review of Best Practices as appropriate
  • Participate in departmental policy review and feedback as it might affect both interactions with other functional groups both within and outside of SABER
  • Develop standards for efficient monitoring practices

Required Qualifications*

  • Bachelor’s degree with at least 3 years of experience, or an equivalent combination of education and work experience in a research setting, preferably as a clinical monitor
  • Implementation of GCPs, 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 (desired)
  • Experience in reading medical records
  • SOCRA or ARCP certified (or obtain within one year of date of hire)
  • Proficient in electronic data capture systems, e.g., OpenClinica
  • 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
  • Takes initiative in process improvement and functions in self-directed manner

Additional Information

We are seeking an experienced and dynamic staff (leader/member) with a commitment to contributing to a diverse, equitable and inclusive environment for all members of our community. 

 

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 will be performed in compliance with the Fair Credit Reporting Act.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.