POSITION SUMMARY:
The Senior Clinical Research Associate (Senior CRA) is responsible for scheduling and conducting on-site and remote monitoring visits in compliance with applicable regulatory standards (MDR, ISO 14155, ICH/GCP guidelines, Teleflex...
impact in advancing clinical research.What You’ll Do:Drive the site monitoring plan by ensuring timely, high-quality delivery in alignment with protocol, SMMP, and project plans.Conduct site initiation, monitoring, and closeout visits, ensuring...
safe shipment, storage, dispensing, return and destruction, as applicable
• The CRA is responsible for adequate monitoring of the clinical trial conduct at the Investigational Sites (e.g., performs monitoring visits at the Sites) during which he/she...
committees/IRBs
Hard & Soft Skills:
• Bachelor’s degree/MD or equivalent in technical-scientific field
• Proved experience in clinicalmonitoring and proven trainings in the field
• Proven GCP-ICH training
• Actual CRA certification as per MoH decree 15/11...
impact in advancing clinical research.
What You’ll Do:
• Drive the site monitoring plan by ensuring timely, high-quality delivery in alignment with protocol, SMMP, and project plans.
• Conduct site initiation, monitoring, and closeout visits, ensuring...
multicenter Phase III trials, including site start-up, recruitment, monitoring, and close-out, in compliance with protocol, GCP, and regulatory standards.
• You act as operational lead within the Clinical Study Team, aligning trial execution with the Clinical...
/commercial/market access Odomzo (sonidegib) indicated for locally advanced basal cell carcinoma
• Lead the process to approval of investigator-initiated trials and monitor progression
• Ensure the appropriate dissemination of clinical and scientific...