Senior Study Start-Up Clinical Research Associate (SSU CRA)
Core
Accelerate the successful start-up of clinical trials across Brazil by leading site selection, activation, and regulatory submissions to bring innovative medicines to patients.
Role type
Senior Study Start-Up Clinical Research Associate
Builds
Clinical trial sites and study activation pipelines (via careerplan.io/jobs/REQ-10087011-senior-study-start-up-clinical-research-associate-ssu-cra-at-novartis)
Domain
Healthcare / Clinical Research
Deliverable
client delivery
Required skills
Site selection and suitability assessment, Study start-up management, Regulatory and ethics committee submissions, GCP compliance, Cross-functional collaboration, Relationship building with investigators
Preferred skills
Negotiation, Stakeholder management
Technologies
Clinical trial management systems (implied by regulatory submissions and TMF)
Responsibilities
Lead site selection and confirm site suitability, Drive study start-up from allocation to green light, Prepare and maintain regulatory and site documentation, Support ethics committee and health authority submissions, Ensure inspection-ready trial master file documentation, Partner with cross-functional teams to resolve issues
Seniority
Senior, hands-on IC