The Research Operations Coordinator provides operational and administrative leadership for the Fezolinetant: Vascular and Brain Function (FAVES-B) clinical trial at the Center for Women’s Biobehavioral Health Research (PI: Rebecca Thurston, PhD). FAVES-B is a clinical trial examining the effects of a treatment for menopausal hot flashes on brain, cognitive, and vascular function in midlife women. This position plays a central role in coordinating the day-to-day conduct of the study, supervising and training research staff, overseeing protocol-driven study procedures and assessments, and supporting high-quality, compliant research operations. The coordinator works closely with study leadership and collaborating teams to ensure efficient study implementation and adherence to ethical, institutional, and regulatory requirements.
This position is grant funded.
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, study visits, 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.
- BSN or BS in related field, Master's preferred.
- Minimum of 3 to 5 years experience in clinical research.
- Successful demonstration of the completion of the competencies required by the department/unit.
- Supervisory skills necessary to plan organize and direct activities of assigned staff.
- Must demonstrate expertise in human relations, ethical-decision making, problem and systems analysis, long and short-term strategic planning and proactive professional behavior.
- Interpersonal and communication skills necessary to establish and maintain effective relationships with staff, investigators and Institutional Review Boards.
- Thorough knowledge of clinical trail design and management, clinical monitoring, database management, FDA regulations and ICH Guidelines.
- MS Office skills include PowerPoint, Excel and Word.
Licensure, Certifications, and Clearances:
- Act 34
UPMC is an Equal Opportunity Employer/Disability/Veteran