Clinical Research Coordinator

Position Summary

The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and management of clinical research studies in accordance with FDA regulations, GCP guidelines, sponsor protocols, and site SOPs. The CRC works closely with Principal Investigators, study sponsors, CROs, and site staff to ensure studies are conducted efficiently, ethically, and with the highest level of data integrity.

Key Responsibilities

Study Coordination & Management

• Coordinate and manage assigned clinical research studies from start-up through close-out
• Ensure protocol adherence and compliance with FDA, ICH-GCP, and IRB requirements
• Prepare for and participate in study initiation visits, monitoring visits, audits, and close-out visits

Participant Recruitment & Study Visits

• Screen, recruit, and consent eligible study participants
• Schedule and conduct study visits per protocol requirements
• Collect, process, and ship biological samples as required
• Educate participants on study procedures and maintain ongoing communication

Data & Documentation

• Accurately enter study data into Electronic Data Capture (EDC) systems
• Maintain complete and organized regulatory binders (ISF)
• Resolve data queries in a timely manner
• Ensure source documentation is accurate, complete, and audit-ready

Regulatory & Compliance

• Assist with IRB submissions, continuing reviews, amendments, and safety reporting
• Maintain investigator credentials and training documentation
• Report adverse events (AEs) and serious adverse events (SAEs) per protocol and regulatory requirements

Collaboration & Communication

• Serve as primary point of contact between site, sponsor, CRO, and vendors
• Communicate study progress, issues, and deviations to the PI and research leadership
• Work collaboratively with physicians, nurses, and administrative staff

Qualifications

Required

• Bachelor’s degree in life sciences, healthcare, or related field (or equivalent experience)
• 1–3 years of clinical research experience (preferred)
• Knowledge of ICH-GCP, FDA regulations, and clinical trial processes
• Strong organizational and time-management skills
• Excellent written and verbal communication skills

Preferred

• Certified Clinical Research Coordinator (CCRC) or CCRP certification
• Experience with EDC systems (e.g., Medidata Rave, REDCap, Oracle)
• Experience in [Therapeutic Area, e.g., oncology, GI, neurology, cardiology]
• Phlebotomy and/or ECG experience

Skills & Competencies

• Attention to detail and accuracy
• Ability to manage multiple studies simultaneously
• Professional and ethical conduct
• Strong problem-solving skills
• Patient-centered approach

Pay: $14.00 - $22.00 per hour

Work Location: In person