Sr. CRA (Level II)
Core
Conduct remote or on-site clinical monitoring visits to assess protocol and regulatory compliance, manage documentation, and ensure audit readiness for clinical trials.
Role type
Senior Clinical Research Associate (Level II)
Builds
Clinical trial data reliability and subject safety
Domain
Pharmaceutical/Biotech clinical research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
risk-based monitoring, root cause analysis, critical thinking, problem-solving, data accuracy verification, physical inventory management, business writing, issue escalation, protocol adherence, ICH-GCP guidelines knowledge, SOP compliance
Preferred skills
mentoring junior team members, project management assistance, trend analysis across sites, investigator meeting participation
Technologies
SDR, SDV, CRF
Responsibilities
Monitor investigator sites using a risk-based approach; ensure data accuracy through document review; assess investigational product inventory; document observations in reports; escalate and resolve deficiencies; maintain contact with sites to confirm protocol adherence; participate in investigator payment processes; provide updates on cross-site trends to the Clinical Team Manager.
Seniority
Senior, hands-on IC