Clinical Research Associate - Germany
Core
Manage investigative sites across Germany to ensure clinical trials are conducted in accordance with study protocols, ICH-GCP, and regulatory requirements.
Role type
Clinical Research Associate II (monitoring)
Builds
Clinical trials for life sciences products
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Site qualification, initiation, monitoring, and close-out visits; Source data verification; Study documentation review; Ethics committee and regulatory submission support; Investigational product accountability management; Trial Master File (TMF) maintenance; Query resolution
Preferred skills
Cross-functional collaboration
Technologies
ICH-GCP, Trial Master File (TMF)
Responsibilities
Conduct site qualification, initiation, monitoring, and close-out visits; Ensure patient safety, data integrity, and protocol compliance; Perform source data verification and review study documentation; Manage site relationships and provide ongoing support to investigators and study staff; Assist with ethics committee and regulatory submissions; Monitor investigational product accountability and site performance; Maintain Trial Master File (TMF) documentation and support query resolution
Seniority
Mid-level, hands-on IC