Sr. Clinical Research Associate (Germany)
Core
Independently performs, coordinates, and oversees all aspects of clinical site monitoring services, assessing protocol and regulatory compliance per ICH/GCP guidelines and local regulations.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical study data integrity and regulatory compliance for pharmaceutical sponsors
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical site monitoring, protocol compliance, data query resolution, clinical supply coordination, site recruitment and setup, audit/inspection participation, mentoring junior CRAs, ICH-GCP knowledge, EDC systems proficiency
Preferred skills
Health Sciences/Life Sciences/Pharmacy/Nursing degree, Sr.CRA/ACRP certification, Phase I–IV trial experience, Master's degree
Technologies
Medidata Rave, Oracle InForm, IRT, eTMF, CTMS
Responsibilities
Conduct onsite and remote site monitoring and close-out visits; ensure data consistency with source documents; coordinate shipment of investigational products and supplies; identify and qualify site investigators; mentor CRA I and II; participate in audits and inspections; optimize patient recruitment; translate site documents when applicable
Seniority
Senior, hands-on IC
