| 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. 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 project managers provide oversight and management of the project team in coordination with study principal investigators and the clinical sites in order to move the project forward efficiently and according to good clinical practice (GCP) guidelines. The position requires travel within the United States and possibly internationally to participating clinical sites and investigator meetings. - Communicate with principal investigators, clinical site investigators, clinical site coordinators, the SABER project team, maintaining positive and cooperative relationships in day-to-day interactions;
- Maintain project timelines and manage timely execution of deliverables by the SABER project team;
- Coordinate and attend investigator and coordinator meetings and teleconferences, including preparing agendas and taking minutes;
- Create and update study manual of operations and standard data collection procedures for all participating clinical sites;
- Participate in the development of study protocols, and create study-specific informed consent document templates
- 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 if necessary, 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, if needed and prepare detailed monitoring visit reports;
- Reconcile study drug usage 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
- Assist with IND initial submissions and annual reports to FDA.
- Coordinate data safety monitoring board meeting organization, and report preparation.
- Prepare IRBMED initial submission for DCC activities as well as annual scheduled renewals
- Academic knowledge in a health science discipline, that is generally associated with a bachelor’s degree;
- At least 3 years of experience in clinical research, preferably as a project manager;
- Able to multi-task and manage competing priorities across multiple projects effectively;
- Excellent interpersonal, oral, and written communication skills with exceptional attention to detail;
- Demonstrated ability to work effectively with physicians, researchers, peers, administrators, and staff of all disciplines to enhance and improve the research experience;
- Demonstrated ability to collaborate in a manner that fosters team building and provides direction for team members;
- Understanding of ICH, GCP and FDA regulations and guidelines with regard to the conduct of human subject research;
- Experience in reviewing medical records;
- Willingness to travel up to 50% of the time, possibly up to 75% at peak times.
- Certification as a clinical research associate or the equivalent is desirable;
- Training/experience as a clinical monitor is desirable;
- Proficient in electronic data capture systems, e.g. OpenClinica, REDCap, Medidata Rave;
- Energized by working in a dynamic research environment
We are seeking an experienced and dynamic staff member with a commitment to contributing to a diverse, equitable and inclusive environment for all members of our community. 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 are performed in compliance with the Fair Credit Reporting Act. The University of Michigan is an equal opportunity/affirmative action employer. |
