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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 and, possibly, to Investigator Meetings.

 

Responsibilities*

  • Provide oversight, project management, project coordination and clinical monitoring for multi-center clinical trials and observational studies;
  • Communicate with the clinical sites, maintaining positive and cooperative relationships in day-to-day interactions with investigators and study sties;
  • Participate in the design, development and execution of clinical trials and observational studies, including:
    • Create and update study manual of operations and standard data collection procedures for all participating clinical sites;
    • Create study-specific informed consent document template;
    • Assist with design of electronic case report forms, database validation and error variables for data entry;
    • Prepare clinical sites for study start-up by reviewing and tracking regulatory documents, ordering start-up supplies, and conducting site initiation visits;
    • Maintain master trial files, and manage the study progress in relation to project timelines;
    • Monitor clinical sites for compliance with GCP and ICH guidelines, including completion of regulatory documents and proper completion of case report forms;
    • Conduct ongoing site monitoring visits, and prepare detailed monitoring visit reports;
    • Reconciliation of study drug with site reporting;
    • Conduct remote source data verification of CRF critical data elements;
    • Screen all adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported to the study sponsor and all participating site IRBs;
    • Attend investigator and coordinator meetings and teleconferences (including preparing agendas and taking minutes);
    • Assist with IND initial submissions and annual reports to FDA;
    • Prepare IRBMED initial submission for the DCC Function and activities as well as annual scheduled renewals.

Required Qualifications*

  • Academic knowledge in a health science discipline, that is generally associated with a bachelor’s degree;
  • At least 3 years’ experience in clinical trials research, preferably as a project manager;
  • Proficient in electronic data capture systems, i.e. OpenClinica;
  • Exceptional attention to detail;
  • Able to multi-task and manage competing priorities effectively;
  • Understanding of ICH, GCP and FDA regulations and guidelines with regard to the conduct of human subject research;
  • Experience in reading medical records;
  • Willingness to travel up to 50% of the time;
  • Certification as a clinical research associate or the equivalent is desirable;
  • Training/experience as a clinical monitor. 

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.