Research Operations Coord

UPMC•Pittsburgh, PA

14h

About The Position

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, led by PI Rebecca Thurston, PhD. FAVES-B examines the effects of a treatment for menopausal hot flashes on brain, cognitive, and vascular function in midlife women. The coordinator plays a central role in coordinating day-to-day study conduct, supervising and training research staff, overseeing protocol-driven procedures and assessments, and supporting high-quality, compliant research operations. The role works closely with study leadership and collaborating teams to ensure efficient implementation and adherence to ethical, institutional, and regulatory requirements. This position is grant funded.

Requirements

BSN or BS in a related field.
Minimum of 3 to 5 years of experience in clinical research.
Successful demonstration of completion of the competencies required by the department/unit.
Supervisory skills necessary to plan, organize, and direct activities of assigned staff.
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 trial design and management, clinical monitoring, database management, FDA regulations, and ICH Guidelines.
MS Office skills, including PowerPoint, Excel, and Word.
Act 34 clearance.

Nice To Haves

Master’s degree preferred.

Responsibilities

Coordinate and oversee day-to-day operations for the FAVES-B clinical trial and support other research activities within the Center as needed.
Work with the Principal Investigator and study leadership to establish and maintain systems and procedures for efficient, high-quality interdisciplinary clinical research.
Supervise, train, and support research staff responsible for recruitment, screening, scheduling, study visits, data collection, and other protocol-driven activities.
Oversee staff training and standardization for study assessments, particularly administration and scoring of standardized cognitive and neuropsychological assessment batteries, protocol adherence, and quality control.
Coordinate 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.
Monitor protocol implementation, staff workload, workflows, recruitment and accrual, participant retention, data completeness, and operational needs; identify problems and work with leadership on solutions.
Collaborate with the Principal Investigator and study team to develop and evaluate recruitment and retention strategies that support enrollment and completion goals.
Support hiring, onboarding, scheduling, training, and development of research personnel, and advise leadership on staffing needs, workload, and operations.
Promote compliance with Good Clinical Practice, FDA and IRB requirements, institutional policies, study protocols, and other applicable ethical and regulatory standards.
Coordinate with investigators, clinical research staff, regulatory personnel, laboratories, imaging and assessment teams, pharmacy, and institutional and external collaborators.
Support preparation and maintenance of materials and systems for safe and effective trial conduct, including manuals, training materials, regulatory and source documentation, data collection tools, and participant-facing materials.
Assist study leadership with research budgets, contracts, purchasing, and allocation of personnel and operational resources.
Monitor data collection processes to promote complete, accurate, timely, and protocol-adherent data acquisition, and help address data quality or operational issues.
Support regulatory and safety oversight, including preparation for monitoring visits, audits, regulatory reviews, and Data and Safety Monitoring Board activities as applicable.
Contribute to development and continuous improvement of research procedures and operational systems within the Center.