FSP Clinical Research Associate II - U.S. Northeast Region - Multiple Therapies
Core
Conducts remote and on-site clinical monitoring of investigator sites to ensure protocol and regulatory compliance, manage documentation, and guarantee subject rights and data reliability.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial data and compliance for multiple therapies
Domain
Clinical Research / Life Sciences
Required skills
Risk-based monitoring, Root cause analysis, Data verification (SDR/SDV/CRF), Investigational product inventory, Regulatory compliance (ICH-GCP), Site initiation and close-out, Travel management
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management System (CTMS) proficiency
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using a risk-based approach; Ensure data accuracy through source data review; Conduct physical inventory of investigational products; Initiate and close out clinical trial sites; Respond to regulatory audits and inspections; Provide trial status tracking and progress reports.
Seniority
Mid-level, hands-on IC
