CRA I / CRA II FSP Denmark
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for clinical trials.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial data and compliance for pharmaceutical and biotech sponsors
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Clinical monitoring, risk-based monitoring, root cause analysis, data verification (SDR/SDV/CRF), ICH-GCP knowledge, site initiation, trial close-out, investigator management
Preferred skills
CNS/Alzheimer's disease therapeutic area knowledge, PPD Drug Development Fellowship completion
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; initiate and close out clinical trial sites; conduct on-site file reviews; track trial status and update study systems; respond to audits and regulatory inspections; facilitate communication between sites, clients, and project teams.
Seniority
Junior to Mid-level, hands-on IC