Clinical Research Associate II - FSP
Core
Seasoned professional responsible for on-site and remote monitoring of clinical research studies in Oncology, Cardiology, or Lupus to ensure patient safety and data integrity.
Role type
Senior Clinical Research Associate (CRA) II
Builds
Clinical trial data and regulatory compliance for biopharma clients
Domain
Clinical Research / Oncology / Cardiology / Lupus
Required skills
Clinical trial monitoring, site management, protocol deviation management, informed consent verification, investigational product inventory, adverse event reporting, regulatory document review, data quality review, risk identification, audit preparation
Preferred skills
Lupus monitoring experience, rare disease monitoring, EDC/EHR monitoring, biopharma therapeutic area experience, site start-up and contract negotiation
Technologies
EDC systems, Trial Management Systems, Electronic Spreadsheets, Word Processing
Responsibilities
Conduct pre-study, initiation, routine, and close-out site visits; manage site start-up including feasibility and recruitment; verify informed consent and patient safety; perform IP inventory and reconciliation; review ISF and TMF; resolve data queries and discrepancies; report Serious Adverse Events; prepare for audits; travel up to 60%.
Seniority
Mid-level, independent contributor
