"Research Compliance Spec Sr"

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 REMEDY team at the University of Michigan (UM) manages the vast portfolio of surgical clinical trials for the Department of Cardiac Surgery. The team consists of varying levels of coordinators dedicated to advancing healthcare to improve outcomes for patients. Our collaborators include investigators from other departments within UM, industries, and Universities. We specialize in multi-center, including international, device trials as well as outcomes research, drug trials, and investigator--initiated studies. As we continue to expand our portfolio, we are looking for detail orientated, highly motivated, compassionate individuals to join our team.

Responsibilities will include, but are not limited to:

• Responsible for study start up for all clinical trials (FDA regulated and non-FDA regulated), including but not limited to: managing CDA in eRPM, feasibility, scheduling/attending site qualification visit, intake, coordinating with the CTSU, completing IRB application(s), V AC committee approval, requesting CDMs, approving billings grids and budgets, collecting regulatory/training documents, and scheduling SIVs.
• Processes study amendments, including reviewing protocol, updating budget, coordinating with the CTSU Amendment team, collecting training documents, updating regulatory binder/shared drive, and submitting IRB amendment.
• Completes study close out, including but not limited to: IRB termination, close out of delegation log, financial reconciliation
• Performs internal audits to ensure study compliance and contributes to corrective and preventative action (CAPA) plans.
• Oversees regulatory documentation for quality assurance.
• Develops SOPs that adapt any established procedures, processes, or workflows to reflect any new or updated regulations and ensures adherence.
• Invoices for department managed clinical studies.
• Assists with preparation for and attends study monitoring visits and external audits.
• Trains staff on state, federal, local, and institutional regulations to ensure compliance

Supervision Received:

This position reports directly to the Clinical Research Manager the Department of Cardiac Surgery.

Supervision Exercised:

None.

Required Qualifications:

• Bachelor's degree or an equivalent combination of related education and experience is necessary.
• Experience in human subjects research compliance
• Minimum 8 years of professional experience in research compliance oversight and/or research experience with biomedical research

Hours/Week: 40 hours

Shift/Hours/Days: Days

The University of Michigan is an equal employment opportunity employer.