Clinical Research Program Manager

Working knowledge of GCP, human subjects protection, IRB processes, and federal research regulations.
Strong leadership, organizational, and problem-solving skills, with the ability to manage multiple concurrent projects and deadlines.
Excellent written and verbal communication skills.
Experience with budgets, research billing, and financial monitoring.
Proficiency with Microsoft Office and research data systems (e.g., REDCap, electronic regulatory binders, clinical trial management systems).
Attention to detail and commitment to confidentiality and ethical research conduct.

Manages and facilitates overall day-to-day research administration activities and operational functions. Collaborates to ensure compliance, productivity, and progress. Develops and implements program policies and procedures and adheres to protocols, regulations, and budgets. Coordinates program events and logistics. Performs budgetary functions.

Manages and facilitates overall day-to-day research administration activities and operational functions. Collaborates to ensure compliance, productivity, and progress. Develops and implements program policies and procedures and adheres to protocols, regulations, and budgets. Coordinates program events and logistics. Performs budgetary functions.

Oversee the day-to-day operations of clinical research studies, including start-up, recruitment, enrollment, retention, data collection, and close-out, ensuring protocols are implemented on schedule and with strong fidelity. Prepare and submit Institutional Review Board (IRB) applications, amendments, continuing reviews, and safety reports; maintain essential and source documentation; and ensure compliance with Good Clinical Practice (GCP), FDA regulations (21 CFR), HIPAA, and NIH requirements. Develop and implement standard operating procedures and quality control checks to verify the accuracy and integrity of data capture; prepare for and respond to audits and monitoring visits. Monitor study budgets and expenditures, work with pre-award and post-award staff on budget development and routine financial reviews, support contract execution, and ensure timely and accurate payments to collaborators and participants. Serve as the primary operational liaison with principal investigators, sponsors, data coordinating centers, study sites, clinical departments, and community partners; schedule and lead routine team meetings and circulate agendas and minutes. Track program metrics and milestones, prepare progress reports and presentations, and assist with grant applications, manuscripts, and other research documents. Perform other duties as assigned.

Oversee the day-to-day operations of clinical research studies, including start-up, recruitment, enrollment, retention, data collection, and close-out, ensuring protocols are implemented on schedule and with strong fidelity. Prepare and submit Institutional Review Board (IRB) applications, amendments, continuing reviews, and safety reports; maintain essential and source documentation; and ensure compliance with Good Clinical Practice (GCP), FDA regulations (21 CFR), HIPAA, and NIH requirements. Develop and implement standard operating procedures and quality control checks to verify the accuracy and integrity of data capture; prepare for and respond to audits and monitoring visits. Monitor study budgets and expenditures, work with pre-award and post-award staff on budget development and routine financial reviews, support contract execution, and ensure timely and accurate payments to collaborators and participants. Serve as the primary operational liaison with principal investigators, sponsors, data coordinating centers, study sites, clinical departments, and community partners; schedule and lead routine team meetings and circulate agendas and minutes. Track program metrics and milestones, prepare progress reports and presentations, and assist with grant applications, manuscripts, and other research documents. Perform other duties as assigned.

The University of Pittsburgh is an equal opportunity employer / disability / veteran.