A cover letter is required for consideration for this position and should be attached as the first page of your resume. Please address your specific interest in this 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 project managers provide project oversight and coordinate the SABER project team efforts in conjunction with study principal investigators or clinical coordinating center leadership. SABER project managers interact directly with clinical sites in order to move the project forward efficiently and according to good clinical practice (GCP) guidelines. The position may require travel, restrictions permitting, within the United States and possibly internationally to participating clinical sites and investigator meetings. You will report to the Project Management and Clinical Monitoring manager.
Communicate with principal investigators, clinical site investigators, clinical site coordinators, the SABER project team, maintaining positive and cooperative relationships in daily interactions
Maintain project timelines and manage SABER project team deliverables
Coordinate and attend investigator and coordinator meetings and web conferences, including preparing agendas and taking minutes
Maintain study manual of operations and standard data collection procedures for all participating clinical sites
Help develop study protocols, and create study-specific informed consent document templates
Help design electronic case report forms, database validation and error variables for data entry
Prepare clinical sites for study startup by reviewing and tracking regulatory documents, ordering startup supplies, and conducting site initiation visits
Maintain master trial files, and manage the study progress in relation to project timelines
Work with clinical monitors to assist with monitoring visits, remote source data verification, and reporting
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
Help with IND initial submissions and annual reports to FDA
Coordinate data safety monitoring board meeting organization, and report preparation
Assist with IRB submissions for DCC activities and annual scheduled renewals
Bachelor's degree in a health science discipline, or an equivalent combination of education and health science work experience
Three or more years of experience in clinical research
Certification as a clinical research associate or the equivalent, or willingness to become certified within two years of hire
Ability to manage competing priorities across multiple projects
Experience working with physicians, researchers, peers, administrators, and staff of all disciplines
Knowledge of ICH, GCP and FDA regulations with regard to the conduct of human subject research
Experience reviewing medical records
In addition to a career filled with purpose and opportunity, The University of Michigan offers a comprehensive benefits package to help you stay well, protect yourself and your family and plan for a secure future. Benefits include:
Generous time off
A retirement plan that provides two-for-one matching contributions with immediate vesting
Many choices for comprehensive health insurance
Long-term disability coverage
Flexible spending accounts for healthcare and dependent care expenses
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.
Job openings are posted for at least seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 198328
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.