Clinical Research Coordinator I

Socket.dev; Pittsburgh (Allegheny County); On-site; USD 65,000 - 85,000; Full time

Job summary

The Center for Women’s Biobehavioral Health Research at the University of Pittsburgh is seeking a Clinical Research Coordinator‑1 to manage day‑to‑day trial operations and regulatory compliance. You will oversee safety, consent, data integrity, and collaboration with clinicians and IDS pharmacists.

Applicants should have nursing qualifications and clinical research experience, with supervision capability and a strong focus on participant safety and quality data collection.

Qualifications

• Associates/Bachelor's preferred; nursing degree required.
• 2 years clinical research experience or 2 years RN experience.
• Current RN licensure in practicing state; BLS/CPR per 30 days of hire.
• Knowledge of regulatory processes and safety oversight.

Responsibilities

• Coordinate day‑to‑day conduct of interventional clinical trial per protocol.
• Ensure protocol‑adherent execution of procedures including lab tests and assessments.
• Lead participant safety monitoring with PI and study physician; report AEs.
• Collaborate with IDS pharmacy for documentation and regulatory compliance.
• Oversee data entry and data quality in study records.
• Lead informed consent processes ensuring understanding and rights.
• Train and supervise staff to ensure high‑quality data collection.
• Collaborate with investigators, clinicians, labs, and stakeholders.
• Support participant retention and adherence through outreach.
• Perform other duties as assigned within institutional competencies.

Skills

Participant safety

Regulatory docs

Clinical coordination

Staff supervision

Education

Bachelor's degree in Nursing

RN Licensure

Tools

EDC systems

Job description

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 within institutional competencies.

• Associates/Bachelor's preferred. Graduation from an accredited school of professional nursing required. 2 years clinical research experience or 2 years of RN experience.

Licensure, Certifications, and Clearances:

Current licensure as a Registered Nurse in practicing state. Pennsylvania employees: Current licensure as a Registered Nurse in practicing state or eligible for State Board Licensure. BLS or CPR required based on AHA standards that include both a didactic and skills demonstration component within 30 days of hire.

• Basic Life Support (BLS) OR Cardiopulmonary Resuscitation (CPR)
• Registered Nurse (RN)
• Act 34

*Current licensure either in the state where the facility is located or, if the facility is in a state covered by the multistate Nursing Licensure Compact (NLC) agreement, a multistate license issued by a participating NLC state. Hires and current employees working on an out-of-state NLC license who later change their residency to the state where the facility is also located will have 60 days upon changing their residency to apply for licensure within that state.

UPMC is an Equal Opportunity Employer/Disability/Veteran