Clinical Research Coordinator III
Core
Manages complex clinical research protocols, screens and enrolls patients, performs basic clinical procedures, and ensures regulatory compliance for pivotal studies.
Role type
Senior Clinical Research Coordinator (III)
Builds
Clinical trial data and patient safety outcomes for complex therapeutic areas
Domain
Clinical Research / Healthcare
Required skills
Good Clinical Practices (GCP), FDA regulations, ICH guidelines, protocol adherence, adverse event reporting, data entry, patient recruitment, site initiation, regulatory document filing, therapeutic area knowledge, phlebotomy, IVRS/EDC systems, MS Office
Preferred skills
Mentoring junior CRCs, leading cross-site communications, driving process improvements, independent study execution
Technologies
Clinical trials database, IVR systems, electronic data capture (EDC), MS Word, MS Excel
Responsibilities
Screen and enroll study subjects, obtain informed consent, perform basic clinical procedures (blood draws, vitals, ECGs), review lab/test results, identify and report adverse events, coordinate site visits, maintain regulatory documentation, assist in recruitment planning, mentor junior CRCs, prepare for audits, lead complex study execution
Seniority
Senior, hands-on IC