CRA(Level II)
Core
Conducts remote or on-site clinical monitoring and site management to ensure protocol compliance, data accuracy, and subject safety across global trials.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial data and regulatory compliance
Domain
Life Sciences / Clinical Research
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Regulatory documentation, Clinical trial close-out, Clinical Team Management System updates
Preferred skills
Life sciences degree, Registered Nursing certification, Medical terminology knowledge, Critical thinking, Problem-solving, Risk management concepts, Communication with medical personnel, Time management, Digital literacy, English language proficiency
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches and root cause analysis; Conduct on-site and remote monitoring for data accuracy and protocol adherence; Initiate and close out clinical trial sites; Ensure completeness of regulatory documents and audit readiness; Facilitate communication between sites, clients, and project teams; Respond to regulatory audits and inspections.
Seniority
Mid-level, hands-on IC