CRA Levels II/Sr - FSP - Portugal
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for pharmaceutical and biotech clients.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial monitoring activities and site management processes
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), ICH-GCP compliance, Protocol adherence, Site initiation and close-out, Investigational product inventory, Regulatory document management
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Data accuracy review (SDR/SDV/CRF), Travel adaptability
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using a risk-based approach to identify and resolve compliance issues; Conduct on-site and remote monitoring activities including data review and inventory checks; Initiate and close out clinical trial sites in collaboration with clients; Ensure audit readiness and maintain essential study documents; Facilitate communication between sites, clients, and project teams; Perform frequent travel (60-80%) to site locations.
Seniority
Mid-level IC