FSP Sr CRA (Level I)
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and compliance assurance 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
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Site initiation, Investigational product inventory, Audit readiness, Clinical trial close-out
Preferred skills
Oncology and Cell therapy domain knowledge, Critical thinking, Problem-solving, Microsoft Office proficiency
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to ensure protocol and regulatory compliance; Conduct on-site and remote monitoring including source data verification (SDV) and critical file review; Initiate clinical trial sites and manage investigator meetings; Ensure audit readiness and maintain essential study documents; Track trial status and generate progress reports; Manage investigator payments and trial close-out procedures.
Seniority
Senior, hands-on IC