Clin Res Project Manager

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.

This position will serve as a Clinical Research Project Manager in the Oncology Clinical Trial Support Unit (O-CTSU) - providing operational and administrative support for the clinical research Quality Assurance Review Core for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN).

Characteristic Duties and Responsibilities:

• Independent knowledge, skills, and abilities within all 8 competency domains is expected.
• As a member of a compliance team, this position independently provides operational and administrative support for the clinical research Quality Assurance Review Core.
• Runs core meetings, establishes meeting agendas, records meeting minutes, and manages outcomes. Provides administrative supervision to a team of 4.
• Ensures all clinical trials receive appropriate auditing compliant with institutional requirements based on study sponsor, intervention(s), and risk to participants.
• Oversees audit documentation for quality assurance.
• Assists the MDQA and Associate Director of Compliance in the strategic direction and implementation planning of core activities.
• Contributes to the development of processes, tools, and trainings to ensure accurate data collection at the site level.
• Provides training and mentorship of other clinical research staff on a range of policies, regulations and best practices.

Qualifications (Clinical Research Project Manager):

• Master's Degree in health science or an equivalent combination of related education and experience is necessary.
• Certification is required through ACRP as CCRC or SoCRA as CCRP or equivalent. Certification must be completed within six months of date of hire.
• Minimum 6 years directly related experience in clinical research compliance oversight and/or clinical research and clinical trials is necessary.