Clinical Research Associate II
Core
Conduct remote or on-site clinical monitoring and site management to ensure protocol and regulatory compliance for pharmaceutical and biotech clinical trials.
Role type
Clinical Research Associate II
Builds
Clinical trials for pharmaceutical and biotech sponsors
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, data accuracy verification (SDR, SDV, CRF review), physical inventory management, regulatory compliance knowledge (ICH-GCP), audit readiness, site initiation, trial close-out
Preferred skills
Business writing, collaborative relationship building, process specialization
Technologies
None explicitly stated
Responsibilities
Monitor investigator sites using a risk-based approach to identify failures and implement corrective actions; Ensure data accuracy through source data review and case report form review; Manage investigator payments and initiate new clinical trial sites; Perform trial close-out and retrieval of trial materials; Ensure essential trial documents are complete and compliant
Seniority
Mid-level individual contributor