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CRA - Swiss CRO

• Conducting site qualification (SEV), site initiation (SIV), interim monitoring (MOV) and close-out visits (COV), documenting the activities carried out, ensuring regulatory, ICH-GCP guideline, protocol and SOPs compliance.
• Responsible to evaluate and supervise site and staff performance, providing adequate and specific training based on ICH-GCP requirements and reporting any serious issue to CPM to promptly develop an action plan.
• Acting as the main reference person for Investigators and clinical site staff in relation to a clinical trial, including support for subject/patient recruitment, retention and awareness strategies.
• BasedonMonitoringPlan:
  • Verify process of obtaining informed consent has been adequately carried out and documented in source documents
  • Assess site processes
  • Conduct appropriate source document review (SDR) and source data verification (SDV) and review of medical records
  • Verifying that AEs and CMs are reported and correctly captured to maintain data integrity and protect patient safety
  • Verify clinical data recorded in case report form (CRF)
  • Control of the supplies, management and accounting of the medical device/IMP
  • Verification of the Investigator's Study File and reconcile content with the Trial Master File (TMF)
• Document activities performed via confirmation letters, follow-up letters, visit reports, track deviations, issues as required and assign action items until resolution.
• For assigned clinical trials, review with assigned CPM assigned activities, project scope, timelines, in order to achieve goals and milestones.

• Fast growing company|Medical Devices and Pharmaceuticals

Master's Degree in scientific disciplines or equivalent experience

At least 2 years of activity as Clinical Research Associate

Swiss CRO based next to Italian border

Permanent swiss contract