Clinical Research Coordinator

About the Role

A rapidly expanding clinical research facility in Bridgeville, PA is looking for an experienced Clinical Research Coordinator to oversee daily clinical trial operations. The role involves participant recruitment, coordinating visits, and ensuring adherence to regulatory standards such as ICH GCP guidelines.

Key Responsibilities

• Manage clinical trial activities aligned with study protocols, FDA directives, and ICH GCP standards
• Identify, screen, and schedule participants for trials
• Facilitate the informed consent process and address participant inquiries
• Conduct fundamental clinical tasks including phlebotomy, vital signs measurement, and electrocardiograms (EKGs)
• Input and oversee data in Electronic Data Capture (EDC) systems and handle data queries
• Maintain documentation including regulatory files, trial logs, and participant records
• Handle reporting of adverse events and protocol deviations
• Arrange participant reimbursements and manage inventory of study supplies
• Assist with monitoring visits by resolving any arising issues
• Maintain clear communication with participants, sponsors, Contract Research Organizations (CROs), and vendors

Candidate Requirements

• Degree in health sciences preferred or an equivalent relevant background
• Minimum two years of experience as a Clinical Research Coordinator in a patient-facing environment
• Proficient knowledge of Good Clinical Practice (GCP), International Air Transport Association (IATA) guidelines, and FDA clinical trial regulations
• Excellent command of English, both written and verbal
• Experience with clinical procedures such as venipuncture, measuring vital signs, and performing ECGs
• Strong interpersonal skills and commitment to customer service
• Ability to work autonomously while managing several priorities simultaneously
• Capable of standing or sitting for long durations and lifting objects up to 30 pounds