Clinical Research Coordinator (CRC)

Position Summary

The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and management of clinical trials (Phase I–IV) at Provecta Research Network. This role serves as the primary point of contact between study participants, investigators, sponsors, and CROs, ensuring that all trial activities are conducted in compliance with the study protocol, FDA regulations (21 CFR Parts 11, 50, 56, 312), ICH-GCP guidelines, and institutional SOPs.

Essential Responsibilities

Study Conduct & Coordination

• Coordinate all aspects of clinical trial execution from site initiation through close-out, including patient screening, enrollment, dosing/treatment visits, and follow-up
• Perform protocol-required assessments including vitals, ECGs, specimen collection, and adverse event documentation
• Maintain accurate, real-time source documentation and case report form (CRF/eCRF) completion
• Manage investigational product (IP) accountability, storage, dispensing, and return logistics in collaboration with pharmacy staff
• Track and report adverse events, serious adverse events, and protocol deviations per sponsor and regulatory requirements

Patient Care & Retention

• Conduct informed consent discussions ensuring participant understanding and voluntary participation
• Serve as the primary liaison for enrolled participants, managing scheduling, visit reminders, travel reimbursement coordination, and retention touchpoints
• Ensure patient safety throughout the study lifecycle, escalating concerns to the Principal Investigator as appropriate

Data & Systems Management

• Enter and manage study data in the Clinical Trial Management System (ClinCompanion/CTMS) and sponsor EDC platforms
• Reconcile source-to-CRF data and resolve queries within sponsor-defined timelines
• Maintain organized and inspection-ready study files (electronic and physical)

Collaboration & Site Support

• Work closely with Principal Investigators, sub-investigators, and site leadership to ensure protocol adherence and patient safety
• Coordinate with regulatory, recruitment, and front desk staff for efficient site operations
• Support and prepare for monitoring visits, audits, and inspections
• Participate in sponsor/CRO calls, team meetings, and ongoing training
• Contribute to CAPA documentation and corrective action implementation as directed