CRA (Level II) to Sr CRA (Level II)
Core
Conduct remote and on-site clinical monitoring visits to assess protocol and regulatory compliance, manage documentation, and ensure data accuracy for pharmaceutical clinical trials.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial monitoring and site management processes for pharmaceutical sponsors
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, data accuracy verification, ICH-GCP compliance, investigator site management, regulatory compliance, medical terminology knowledge
Preferred skills
Registered Nursing certification, life sciences degree, clinical trial experience, travel adaptability
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches, ensure data accuracy through source data review, assess investigational product inventory, escalate and resolve site deficiencies, initiate and close out clinical trial sites, conduct on-site file reviews, track trial status and progress, facilitate communication between sites and project teams
Seniority
Mid-level IC (2+ years experience)