Research Quality Specialist - Lead

at  The University of Pittsburgh

RESEARCH QUALITY SPECIALIST - LEAD

Med-Surgery - Pennsylvania-Pittsburgh - (24006351)
The Department of Surgery’s Trauma and Transfusion Medicine Research Center (TTMRC) is looking for a Site Monitor to provide site support for the Biomedical Advanced Research and Development Authority (BARDA) study. The incumbent will utilize their medical and drug development experience to oversee the conduct and evaluation of this clinical trial. Responsibilities will include but are not limited to education and support of clinical study sites, assessment of drug safety, collaboration with regulatory authorities, and other aspects of study conduct and oversight as needed. The Site Monitor will be highly engaged, collaborative and work cross-functionally with key stake holders as required. They will conduct monitoring visits with participating research sites remotely or when needed, on site to ensure that the research study is being conducted and complies with the requirements of the approved study protocol guidelines. Must be all to follow the University of Pittsburgh and HIPPA compliance policies.

JOB SUMMARY

Coordinates on-site reviews of selected clinical projects to assess compliance with federal regulations, Institutional Review Board (IRB) requirements, and University policies. Monitors and evaluates site visit auditors work and oversees the drug distribution and delivery system. Writes audit reports, facilitates educational programs for the research community, updates information as pertains to federal regulations and applicable policies, and analyzes and conveys audit data to assist in addressing inaccuracies.

MINIMUM EDUCATION LEVEL REQUIRED

Bachelor’s Degree

WILL THIS POSITION ACCEPT SUBSTITUTION IN LIEU OF EDUCATION OR EXPERIENCE?

Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.

Position may require travel to clinical sites across the US.