Part-Time CRA II - Klinischer Monitor (0.8 FTE) (m/w/d)
Core
Conducts remote and on-site clinical monitoring of investigator sites to ensure protocol and regulatory compliance, data accuracy, and subject safety across global clinical trials.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial programs for pharmaceutical and biotech clients
Domain
Life Sciences / Clinical Research
Required skills
Clinical monitoring, ICH-GCP guidelines, Risk-Based Monitoring (RBM), Root Cause Analysis (RCA), Site initiation and close-out, Data review (SDR/SDV/CRF), Investigational product inventory
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management Systems (CTMS), Travel adaptability
Technologies
Microsoft Office, Clinical Trial Management Systems (CTMS)
Responsibilities
Perform on-site and remote monitoring visits to assess compliance and data accuracy; Identify and resolve site process failures using root cause analysis; Ensure audit readiness and maintain essential study documents; Coordinate investigator payments and site initiation; Track trial progress and report to Clinical Team Manager; Facilitate communication between sites, clients, and project teams.
Seniority
Mid-level, hands-on IC