Clinical Research Coordinator II- India
Core
Coordinate and execute clinical trial activities, participant recruitment, and data management to ensure protocol compliance and participant safety.
Role type
Clinical Research Coordinator (CRC)
Builds
Clinical research studies for sponsors in gastrointestinal, hepatology, obesity, and cardiology
Domain
Clinical research / Healthcare
Required skills
ICH-GCP guidelines, Indian clinical research regulations (CDSCO/ICMR), clinical trial documentation, EDC systems, CTMS, informed consent processes, laboratory specimen handling, regulatory compliance
Preferred skills
Centralized clinical operations experience, multiple site management, clinical research technologies (eSource, EMR/EHR)
Responsibilities
Coordinate participant recruitment, pre-screening, enrollment, and follow-up; Obtain informed consent; Process and ship laboratory specimens; Maintain source documentation and eCRFs; Enter data into EDC systems; Coordinate investigational product accountability; Support study startup and site activation; Prepare for sponsor monitoring visits and audits; Ensure regulatory compliance
Seniority
Mid-level, hands-on IC