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Job Description
Description The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination, implementation, management, and completion of clinical research trials in accordance with trial protocols, Good Clinical Practice (GCP), federal regulations, and site standard operating procedures.
Primary responsibilities include:
Recruiting, screening, and enrolling trial participants according to protocol requirements. Conducting the informed consent process and ensuring participants fully understand trial procedures, risks, and benefits. Educating participants and caregivers regarding trial expectations, visit schedules, investigational products, and protocol requirements. Scheduling, coordinating, and conducting trial visits and protocol-required procedures. Collecting, documenting, and maintaining accurate source documentation and trial records. Entering and reviewing trial data in electronic data capture systems and resolving data queries in a timely manner. Monitoring participant safety and promptly reporting adverse events and protocol deviations as required. Maintaining regulatory documents, investigator site files, and trial binders in accordance with sponsor and regulatory requirements. Coordinating with investigators, sponsors, contract research organizations, trial monitors, laboratories, and other trial vendors. Preparing for and participating in sponsor monitoring visits, audits, and regulatory inspections. Managing trial supplies, investigational product accountability, and laboratory shipments as applicable. Tracking enrollment goals, trial timelines, and participant retention activities. Ensuring compliance with trial protocols, Good Clinical Practice, HIPAA, and applicable federal and state regulations. Assisting with trial start-up activities, site initiation visits, and trial closeout procedures. Performing other research-related duties as assigned to support the successful conduct of clinical trials. Requirements Licensed Vocational Nurse, Associate degree, Bachelor's degree in a healthcare, life science, or related field. Experience working in a medical or healthcare environment preferred. Clinical research experience is preferred but not required. Demonstrated proficiency with Microsoft Word, Outlook, Excel, and other office software applications. Comfortable working in a highly digital environment with multiple software applications and web-based platforms. Ability to efficiently manage electronic documents, navigate shared network drives, maintain organized electronic filing systems, and learn sponsor-specific web-based platforms. Strong written and verbal communication skills, including professional correspondence with trial participants, sponsors, monitors, and vendors. Excellent organizational and project management skills with the ability to prioritize competing responsibilities and manage multiple clinical trials simultaneously. Strong critical thinking, problem-solving, and attention-to-detail skills. Ability to work independently, take initiative, and remain self-motivated in a fast-paced research environment. Ability to follow trial protocols, regulatory requirements, and site standard operating procedures with a high degree of accuracy.
