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.
Job Requirement
- RN, LVN, or Bachelor's degree in a healthcare, life science, or related field.
- Experience working in a medical or healthcare environment preferred.
- 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 manage electronic documents efficiently, 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.
