CRA I - FSP
Core
Conducts remote and on-site clinical monitoring and site management to ensure protocol compliance, data accuracy, and subject safety across investigational sites in India.
Role type
Junior Clinical Research Associate (On-site/Remote)
Builds
Clinical trial sites and monitoring activities for sponsors
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ICH-GCP compliance, Source Data Verification (SDV), Source Data Review (SDR), risk-based monitoring, root cause analysis, site initiation, regulatory documentation, clinical trial close-out
Preferred skills
Oncology trial experience, Master's in Pharmacy, advanced risk-based monitoring concepts
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based monitoring; perform Source Data Verification and Case Report Form review; initiate clinical trial sites; conduct on-site file reviews; perform trial close-out activities; track study progress and update systems; facilitate communication between sites, clients, and internal teams.
Seniority
Junior, hands-on IC