Clinical Trials Operations Lead

UPMC; Pittsburgh (Allegheny County); On-site; USD 60,000 - 80,000; Full time

Job summary

UPMC is seeking a Research Operations Coordinator to provide operational and administrative leadership for the FAVES-B clinical trial at the Center for Women’s Biobehavioral Health Research. You will coordinate day-to-day study activities and support regulatory compliance.

You will supervise staff, implement study procedures, and collaborate with investigators to ensure high-quality, ethical research operations and efficient study execution.

Qualifications

• Experience coordinating complex interdisciplinary clinical research.
• Ability to supervise and train research staff.
• Knowledge of GCP, FDA regulations, and IRB processes.

Responsibilities

• Coordinate and oversee day-to-day research operations for the Fezolinetant: Vascular and Brain Function (FAVES-B) clinical trial and support other research activities within the Center for Women’s Biobehavioral Health Research as needed.
• Work closely with the Principal Investigator and study leadership to implement and maintain systems and procedures necessary for the efficient, high-quality conduct of complex interdisciplinary clinical research.
• Supervise, train, and support research staff responsible for participant recruitment, screening, scheduling, data collection, and other protocol-driven activities.
• Oversee staff training and standardization for study assessments, with particular emphasis on the administration and scoring of standardized cognitive and neuropsychological assessment batteries, protocol adherence, and quality control.
• Coordinate the implementation of FAVES-B study procedures involving cognitive, vascular, laboratory, behavioral, ambulatory/wearable monitoring, electronic diary, and other protocol-defined assessments.
• Develop, maintain, and revise study-specific training materials, standard operating procedures, workflows, manuals, and related resources necessary for consistent implementation of research protocols.
• Monitor protocol implementation, staff workload, study workflows, recruitment and accrual, participant retention, data completeness, and other operational study needs; identify problems and work with study leadership to implement solutions.
• Collaborate with the Principal Investigator and study team to develop and evaluate recruitment and retention strategies designed to meet study enrollment and completion goals.
• Support hiring, onboarding, scheduling, training, and ongoing development of research personnel and provide input to leadership regarding staffing needs, workload, and research operations.
• Promote compliance with Good Clinical Practice (GCP), FDA requirements, IRB requirements, institutional policies, study protocols, and other applicable ethical and regulatory standards.
• Coordinate with the Principal Investigator, study investigators, clinical research staff, regulatory personnel, laboratories, imaging and assessment teams, pharmacy, and other institutional and external collaborators to support effective study implementation.
• Support preparation and maintenance of study materials and systems required for safe and effective trial conduct, including study manuals, training materials, regulatory documentation, source documentation, data collection tools, and participant-facing materials.
• Assist study leadership with research budgets, contracts, purchasing, and allocation of personnel and operational resources in accordance with study needs and institutional requirements.
• Monitor study data collection processes to promote complete, accurate, timely, and protocol-adherent data acquisition, and work with research staff and investigators to address data quality or operational issues.
• Support regulatory and safety oversight activities, including preparation for monitoring visits, audits, regulatory reviews, and Data and Safety Monitoring Board activities as applicable.
• Contribute to the development and continuous improvement of research procedures and operational systems within the Center for Women’s Biobehavioral Health Research.

Skills

Research coordination

Staff supervision

Training and onboarding

Regulatory compliance

Budget support

Process improvement

Data collection

Job description

UPMC is seeking a Research Operations Coordinator to provide operational and administrative leadership for the FAVES-B clinical trial at the Center for Women’s Biobehavioral Health Research. You will coordinate day-to-day study activities and support regulatory compliance.

You will supervise staff, implement study procedures, and collaborate with investigators to ensure high-quality, ethical research operations and efficient study execution.