Senior Clinical Research Associate (senior Site Manager)
Johnson & Johnson
Prague, Czechia
Fully remote
Gcp compliance
Site monitoring
Protocol adherence
This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with protocols, SOPs, GCP, and applicable regulations
Job Summary
This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with protocols, SOPs, GCP, and applicable regulations.
Responsibilities include site initiation, monitoring, management, and close-out, ensuring site staff are trained, data is accurate, and adverse events are reported promptly.
The company fosters an inclusive work environment where diversity and individual dignity are respected, and employees are considered valuable.
Matching Summary
This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with protocols, SOPs, GCP, and applicable regulations.
Skills & Requirements
Must-have
GCP compliance
site monitoring
protocol adherence
regulatory guidelines
investigator meetings
essential document management
Nice-to-have
therapeutic area knowledge
process improvement contribution
coaching and mentoring
special initiatives participation
proactive problem solving
Key Requirements
Minimum 2 years clinical trial monitoring experience
BA or BS degree in Pharmacy, Nursing, Life Sciences or related field
Proficient in speaking and writing Czech and English