Senior Clinical Research Coordinator

Clinical Research Coordinator - Clinical Site Network

Locations:

Orlando, FL | Los Angeles, CA | Raleigh, NC | Philadelphia, PA | Boston, MA

Position Overview:

We are seeking a highly organized and proactive Clinical Research Coordinator (CRC) to support a growing network of clinical research sites across multiple U.S. locations. This role will play a critical part in the day-to-day execution of clinical trials, ensuring compliance with protocol requirements, regulatory standards, and high-quality patient care.

The ideal candidate will have hands-on experience coordinating clinical studies and thrive in a fast-paced, multi-site environment, with the ability to collaborate across geographically dispersed teams.

Key Responsibilities:

Study Coordination & Execution

• Coordinate and manage clinical trials from start-up through close-out in accordance with protocols, SOPs, and regulatory requirements
• Schedule and conduct subject visits, including screening, enrollment, and follow-ups
• Ensure accurate and timely data collection, entry, and query resolution in EDC systems
• Maintain source documentation and ensure ALCOA+ principles are upheld

Patient Recruitment & Retention

• Support patient recruitment strategies across sites to meet enrollment targets
• Pre-screen and consent study participants in compliance with GCP and ethical guidelines
• Build strong relationships with patients to ensure retention and protocol adherence

Regulatory & Compliance

• Prepare and maintain regulatory binders and essential documents
• Ensure compliance with ICH-GCP, FDA regulations, and institutional policies
• Assist with IRB/EC submissions, amendments, and continuing reviews
• Support audit and inspection readiness activities

Site & Sponsor Collaboration

• Act as a key point of contact for monitors (CRAs), sponsors, and CROs
• Support monitoring visits (SIV, IMV, COV) and follow-up on action items
• Collaborate across multiple sites within the network to ensure consistency and best practices

Operational Support

• Track study timelines, enrollment metrics, and site performance
• Assist with investigational product (IP) accountability and storage
• Coordinate lab samples, shipments, and vendor interactions
• Support financial tracking (e.g., visit billing, sponsor payments where applicable)

Qualifications:

Education:

• Bachelor’s degree in Life Sciences, Nursing, or a related field preferred
• Clinical Research Certification (e.g., ACRP, SOCRA) is a plus