Clinical Trials Administrator - India
Core
Coordinate clinical trial activities from study set-up through closeout, ensuring accurate documentation, data quality, regulatory compliance, and timely project deliverables for laboratory-based clinical studies.
Role type
Clinical Trials Administrator (Study Support)
Builds
Clinical trial study binders, protocol documentation, logistics supply chains, and quality-controlled data records.
Domain
Clinical Research / Contract Research Organization (CRO) / Laboratory Operations
Required skills
Protocol set-up and documentation, LIMS and LabStar WIN system management, site list and contact management, logistics coordination for phlebotomy kits, quality control (QC) of study documents and binders, query resolution, regulatory compliance (ICH-GCP, GDP), report generation and metrics monitoring, inventory management.
Preferred skills
Relational databases, reporting tools, multi-tasking, problem-solving, customer service.
Technologies
LIMS, LabStar WIN, KOM (Kit Order Manager), relational databases, reporting tools.
Responsibilities
Review clinical trial protocols and develop protocol test summaries, global laboratory specifications, and operating procedures; coordinate with sponsors, CROs, and laboratory teams; manage site lists and add/remove contacts in LIMS; handle logistics for phlebotomy kit assembly and transport; perform secondary binder QC reviews and submit finalized binders for archival; resolve data queries and unlabelled samples; generate custom reports for study metrics and trends; participate in study conference calls and document action items.
Seniority
Junior to Mid-level, hands-on IC
