Clinical Research Associate (Level I/II)
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site lifecycle activities, and guarantee data reliability for pharmaceutical clinical trials.
Role type
Clinical Research Associate (Level I/II)
Builds
Clinical trial data and compliance reports for pharmaceutical sponsors
Domain
Life Sciences / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based site monitoring, Protocol compliance verification, Data accuracy (SDR/SDV/CRF), Investigational product accountability, Root cause analysis, Corrective/preventive action (CAPA) implementation, Site lifecycle management (feasibility, initiation, routine, close-out), Regulatory adherence (ICH-GCP), Trial documentation management, Audit support, Stakeholder liaison
Preferred skills
None stated
Technologies
CTMS
Responsibilities
Conduct risk-based site monitoring (on-site and remote), Manage site lifecycle activities, Maintain trial documentation and systems, Act as key liaison between sites and sponsor, Support audits and inspections
Seniority
Entry to Mid-level, hands-on IC