Research Quality Specialist-Lead

The research Quality Specialist Lead is responsible for conducting on-site and remote monitoring visit activities for multicenter human clinical research studies conducted by the LITES Network within the Department of Surgery. This position ensures that participating research sites conduct studies in accordance with approved study protocols, applicable federal regulations, and Good Clinical Practice (GCP) guidelines. The Research Quality Specialist Lead will serve as a key resource for study sites by identifying compliance issues, providing education, and promoting the consistent implementation of study procedures.

Preferred Qualifications:

• Experience monitoring multicenter human clinical trials.
• Ability to work independently, manage multiple studies simultaneously, and prioritize competing deadlines.
• Strong analytical, organizational, and problem-solving skills with exceptional attention to detail.

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.

• Will need to be able to conduct a variety of monitoring activities, including but not limited to: reviewing site's electronic study data to ensure it is consistent with source documentation, verifying that regulatory requirements are being met, confirming that studies are conducted in accordance with FDA Good Clinical Practice (GCP) regulations, and compiling reports.
• Must demonstrate excellent written and verbal communicaton skills, including the ability to lead meetings and education sessions with internal and external partners.
• Must be able to travel to participating research sites as required, including some air and overnight travel.
• Must demonstrate proficiency in Microsoft Office applications (Word, Excel, Outlook, Teams)

This position requires the ability to travel, including local and out-of-state travel by automobile and commercial airline. The incumbent must be able to sit, stand, and walk for extended periods, transport and carry a laptop computer, monitoring materials, and other work-related equipment weighing up to 20 pounds; and perform repetitive tasks such as computer use, document review, and data entry. The position requires the ability to occasionally bend, reach, and climb stairs.