Clinical Research Coordinator I

The Center for Women’s Biobehavioral Health Research (PI: Rebecca Thurston) is devoted to understanding and enhancing women’s health at midlife and beyond. The Center, located in Sterling Plaza, is within the Department of Psychiatry at the University of Pittsburgh. 

The Clinical Research Coordinator-1 plays a central leadership role in the day‑to‑day coordination and regulatory conduct of multiple studies at the Center. Studies include an industry‑sponsored clinical trial evaluating how a treatment for menopausal hot flashes may impact brain, cognitive, and vascular function in midlife women, and the Study of Women Across the Nation (SWAN) investigation, a longitudinal study generating nationally representative insights into women’s health and experience.

This position requires prior experience coordinating clinical trials and demonstrated competence in participant safety oversight, regulatory documentation, and protocol‑driven research operations. Experience in women’s health, clinical, or epidemiological research, staff supervision and training, and/or phlebotomy is highly preferred.

This position is grant funded.

Responsibilities:

• Coordinate and oversee day‑to‑day conduct of an interventional clinical trial, including participant recruitment, screening, enrollment, and scheduling in accordance with protocol‑defined inclusion/exclusion criteria.

• Ensure high‑quality, protocol‑adherent execution of all study procedures, including laboratory testing, ambulatory/wearable monitoring, electronic diaries, behavioral and neurocognitive assessments, and other study evaluations.

• Lead participant safety monitoring in collaboration with the study physician and Principal Investigator, including assessment, documentation, and timely reporting of adverse events (AEs), and protocol‑defined events of special interest in accordance with regulatory and institutional requirements.

• Collaborate with the Investigational Drug Service (IDS) pharmacy, ensuring accurate documentation and compliance with protocol and regulatory standards.

• Oversee accurate and timely data entry, and data quality.

• Lead informed consent processes, ensuring participant comprehension, safety, rights, and well‑being.

• Train and supervise research staff to ensure consistent, high‑quality data collection and documentation.

• Collaborate closely with investigators, study physician, pharmacists, laboratories, and other stakeholders to support efficient and compliant study execution.

• Support participant retention and adherence using participant‑centered

• Perform other duties as assigned and in accordance with institutional competencies.