Clinical Research Coordinator II
Core
Utilize Good Clinical Practices (GCP) to screen, enroll, and monitor clinical research study subjects while ensuring protocol and regulatory compliance.
Role type
Senior Clinical Research Coordinator (II)
Builds
Clinical trials for medical research
Domain
Healthcare / Clinical Research
Required skills
Good Clinical Practices (GCP), FDA regulations, ICH guidelines, phlebotomy, vital signs measurement, ECG interpretation, informed consent, adverse event reporting, data entry, regulatory documentation, patient recruitment, study medication management
Preferred skills
Care Access Research experience, California/Louisiana/Washington/Nevada state-specific phlebotomy certification, laboratory assistant certification
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); monitor quality metrics and resolve queries; identify and report adverse events; coordinate site visits; mentor CRC I peers; manage study medication inventory and dispensation; document data in real-time; assist with regulatory filings.
Seniority
Senior, hands-on IC