Clinical Research Associate (Level I or II)
Core
Conduct remote or on-site clinical monitoring and site management to ensure trial compliance with protocols, ICH-GCP guidelines, and regulations.
Role type
Clinical Research Associate (Level I)
Builds
Clinical trials for pharmaceutical/biotech sponsors
Domain
Life Sciences / Clinical Research
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), ICH-GCP knowledge, Protocol adherence, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Time management, Team collaboration
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approach; Ensure data accuracy via SDR, SDV, and CRF review; Manage procedures and guidelines from various sponsors; Conduct on-site file reviews and trial close-out; Facilitate communication between sites, client, and project team; Respond to audits and inspections.
Seniority
Entry-level (1 year experience or fellowship equivalent)