Sr CRA I/II - FSP - Norway
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and regulatory compliance for clinical trials in oncology and cell therapy.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research / Oncology / Cell Therapy
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP guidelines, site initiation, data review (SDR/SDV/CRF), investigator management
Preferred skills
Oncology or cell therapy therapeutic area knowledge, clinical trial management systems proficiency
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to ensure protocol and regulatory compliance; Initiate and manage clinical trial sites; Conduct on-site and remote monitoring activities including data review and inventory checks; Prepare reports and track trial status; Ensure audit readiness and document management; Facilitate communication between sites, clients, and project teams.
Seniority
Senior, hands-on IC
