CRA & CTA - Pharmaceutical Consultancy
Core
Clinical Research & Technical Associate responsible for on-site monitoring, regulatory compliance, and documentation support across the full lifecycle of observational studies.
Role type
Clinical Research Associate (CRA) / Clinical Trial Associate (CTA)
Builds
Observational studies
Domain
Pharmaceutical / Clinical Research
Deliverable
client delivery
Required skills
Regulatory affairs, document management, site monitoring, data validation, compliance with ICH-GCP and EU regulations, audit support, scientific reporting
Preferred skills
None stated
Technologies
eTMF systems, EDC systems
Responsibilities
Prepare and submit study documentation to Ethics Committees and regulatory authorities; Maintain Trial Master File (TMF) and Investigator Site Files (ISF); Monitor study sites for protocol adherence and conduct initiation/close-out visits; Review and validate Case Report Forms (CRFs); Ensure compliance with ICH-GCP, EU, and Spanish regulations; Contribute to clinical study reports and scientific publications.
Seniority
Mid-level IC
