Clinical Research Associate II
Core
Coordinate clinical monitoring and site management to ensure protocol and regulatory compliance across pharmaceutical and biotech clinical trials.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trials for pharmaceutical and biotech sponsors
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, Investigational site management, Data review (SDR/SDV/CRF), Investigational product inventory, Audit readiness, Regulatory compliance
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management System (CTMS) proficiency, Process improvement initiatives
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; Conduct on-site and remote monitoring activities including data and product inventory reviews; Initiate and close out clinical trial sites; Ensure essential study documents are complete and compliant; Facilitate communication between sites, clients, and project teams; Respond to regulatory audits and inspections.
Seniority
Mid-level, hands-on IC