Lavori attuali relativi a Cra - Swiss Cro - Como - Page Personnel Italia

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.
- Based onMonitoringPlan:

- 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

For CRO based in Switzerland i'm looking for a CRA