Sr. Clinical Research Associate (Germany)
Core
Independent monitoring of investigational sites to ensure clinical studies are performed according to trial protocol and in compliance with regulations and GCP.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trials for pharmaceuticals and biologics
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Site initiation and close-out monitoring, Protocol and GCP compliance, Regulatory affairs knowledge, Site relationship management, Issue resolution and escalation, Study startup and contracting
Preferred skills
Oncology or rare disease trial experience, Agile environment adaptability
Technologies
None stated
Responsibilities
Manage site initiation, routine monitoring, and close-out visits; Ensure compliance with protocols, GCP, ICH, and SOPs; Build strong site relationships; Identify and resolve site issues; Execute regulatory affairs and site activation activities
Seniority
Senior, hands-on IC
