FSP CRA I/II Gen Med - Respiratory - HIV - Oncology
Core
Conduct remote or on-site clinical monitoring and site management to ensure protocol and regulatory compliance for pharmaceutical trials.
Role type
Clinical Research Associate (Level I or II)
Builds
Clinical trial data reliability and subject safety
Domain
Life Sciences / Clinical Research
Required skills
Clinical monitoring, ICH-GCP guidelines, Risk Based Monitoring, Root Cause Analysis, Data verification (SDR/SDV/CRF), Investigational product inventory, Regulatory compliance
Preferred skills
Respiratory, HIV, or Oncology therapeutic area knowledge
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches, ensure data accuracy through document review, manage investigator payments, initiate and close out clinical trial sites, respond to audits and inspections, facilitate communication between sites and sponsors.
Seniority
Entry to Mid-level, hands-on IC
