Clinical Research Coordinator

@ Illinois Bone and Joint Institute LLC

Job Summary

The Clinical Research Coordinator is responsible for supporting the planning, coordination, and execution of clinical trials and research studies, ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards. This role involves working closely with the Principal Investigator and cross-functional teams to guarantee high-quality and compliant research conduct.

Key Responsibilities

• Coordinate study start-up activities including IRB submissions.
• Enter and manage data in EDC systems and maintain documentation.
• Track adverse events, deviations, and compliance issues.
• Liaise with sponsors, CROs, and institutional departments.
• Maintain subject logs, regulatory binders, and study documentation.
• Prepare for monitoring visits and audits.
• Coordinate with internal teams and external vendors to meet timelines.
• Maintain study supply and equipment inventory.
• Coordinate reimbursement for study subjects.
• Screen, recruit, and consent participants following protocols.
• Conduct study visits and collect source documentation.
• Perform other assigned job functions.

Requirements

Required: Bachelor’s degree in a health-related field or equivalent experience, 2+ years of clinical research coordination, knowledge of GCP, FDA regulations, HIPAA, excellent communication, organizational and time-management skills, and experience with EDC systems and EMR platforms.

Preferred: Certified Clinical Research Coordinator (CCRC) or equivalent credential and experience in orthopedic, rheumatologic, surgical, therapeutic, and/or device trials.

Work Environment

This role is based in a clinical and office environment with a hybrid work model, requiring travel to clinical sites as needed (own transportation required). Benefits include medical, dental, vision, life and AD&D insurance, disability coverage, 401k with match, profit sharing, wellness program, flexible spending accounts, and paid holidays/time off.

Key skills/competency

Clinical Research Coordinator, trials, GCP, regulatory, compliance, data management, recruitment, IRB, documentation, monitoring