The Senior Clinical Research Associate acts as the main contact with study sites to ensure proper delivery of clinical studies in compliance with ICH-GCP
Job Summary
The Senior Clinical Research Associate acts as the main contact with study sites to ensure proper delivery of clinical studies in compliance with ICH-GCP.
Responsibilities include preparing, initiating, monitoring, and closing assigned sites while managing study supplies and drug accountability.
The role requires active participation in Local Study Team meetings and driving performance by proactively identifying and resolving study-related issues.
Matching Summary
The Senior Clinical Research Associate acts as the main contact with study sites to ensure proper delivery of clinical studies in compliance with ICH-GCP.
Skills & Requirements
Must-have
ICH-GCP international guidelines knowledge
Site initiation and monitoring visits
Source data verification and review
Risk Based Quality Management principles
CTMS system proficiency
Serious adverse event reporting
Nice-to-have
Experience with AstraZeneca procedural documents
Ability to tutor junior colleagues
Strong negotiation skills for site interactions
Collaboration with local Medical Science Liaisons
Inspection readiness preparation experience
Key Requirements
Bachelor degree in life science or related discipline
Excellent knowledge of ICH-GCP guidelines
Good medical knowledge and ability to learn therapeutic areas