Clinical Research Coordinator

Work Location: Allegheny County, Pennsylvania

Summary:

The Clinical Research Coordinator is responsible for supporting and coordinating clinical research trials in accordance with study protocols and regulatory guidelines. This full-time, on-site position involves direct interaction with trial participants, data management, regulatory documentation, and clinical procedures.

Responsibilities:

• Coordinate and perform clinical trial activities, including participant pre-screening, recruitment, scheduling, and conducting participant visits.
• Maintain and update regulatory documents, trial logs, and participant charts, ensuring compliance with FDA, GCP, and ICH guidelines.
• Conduct informed consent discussions with trial participants and address study-related questions.
• Enter and manage data in electronic data capture systems, resolve queries, and apply good documentation practices.
• Manage and report adverse events, serious adverse events, and protocol deviations in a timely manner.
• Perform basic laboratory and clinical procedures such as phlebotomy, blood pressure, vitals, EKGs, and specimen handling.
• Communicate effectively with coworkers, leadership, trial participants, sponsors, CROs, and vendors.
• Support technology setup and maintenance for studies, adhere to federal regulations regarding protected health information, and perform additional assigned duties.

Qualifications:

• College degree in health sciences preferred, or significant relevant experience.
• Minimum of 2 years of experience as a Clinical Research Coordinator in a direct patient care role.
• Knowledge of Good Clinical Practice (GCP), IATA, and FDA regulations related to clinical trials.
• Fluency in written and spoken English.
• Ability to perform clinical procedures including phlebotomy, vitals, height, weight, and ECGs.

Published Category: Clinical Operations & Development