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.
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 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
Provide oversight and assistance to clinical monitors with monitoring visits, remote source data verification, and reporting
Oversee the safety data reporting process to ensure that all AEs/SAEs are reported according to the data safety and monitoring plan
Help with IND initial submissions and annual reports to FDA
Coordinate data safety monitoring board meeting organization, and report preparation
Help with IRB submissions for DCC activities and annual scheduled renewals
Participate in SABER team meetings and activities and contribute to process improvement plans
Bachelor's degree in a health science discipline, or an equivalent combination of education and health science work experience
2+ years of experience in clinical research
Certification as a clinical research associate or the equivalent, or willingness to become certified within three years of hire
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. For more information, please visit: https://careers.umich.edu/benefits/.
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.
U-M COVID-19 Vaccination Policy
COVID-19 vaccinations are now required for all University of Michigan students, faculty and staff across all three campuses, including Michigan Medicine. This includes those working or learning remotely. More information on this policy is available on the Campus Blueprint website or the U-M Dearborn and U-M Flint websites.
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.