Clinical Research Associates
Core
Own site activation and performance, direct risk-based monitoring, and safeguard patient safety and data integrity for clinical trials in Oncology and Cell Therapy.
Role type
Clinical Research Associate (Site Management and Monitoring)
Builds
High-quality, patient-centric clinical trials translating deep biology into breakthrough medicines.
Domain
BioPharma, Oncology, Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Site selection and activation, ICH-GCP and country regulations knowledge, remote and onsite monitoring, Source Data Review (SDR) and Source Data Verification (SDV), Case Report Form (CRF) review, data query management, CTMS and eTMF proficiency, Serious Adverse Event (SAE) reporting, risk-based monitoring adjustment.
Preferred skills
RbQM analytics and dashboards usage, multi-country study experience, audit and inspection readiness coaching, remote monitoring tools familiarity, eSource/ePRO data-driven decision-making.
Technologies
CTMS, eTMF, RbQM, eSource, ePRO
Responsibilities
Identify and evaluate sites and investigators to drive activation and enrolment; Coordinate EC/IRB and health-authority submissions; Train and support site teams on compliance routines; Conduct remote and onsite monitoring visits and manage data queries; Ensure timely reporting of Serious Adverse Events; Maintain CTMS and eTMF accuracy and manage study drug supplies.
Seniority
Mid-level, hands-on IC
