Permanent Senior CRA - Homebased - Rome & surrounding areas
- Experience Level
- Experienced (non-manager)
As part of a recent request from one of our CRO Partners, Upsilon Global are looking for a Senior CRA with a minimum of 4 years independent monitoring experience who is seeking to join a growing team of clinical professionals who will monitor key sites across Italy. The role is homebased, but ideal candidates will be based in Rome or it's surrounding areas.
Working as part of a small team, you’ll work on multiple studies, most likely within Oncology, Rare Diseases, Gene Therapy or Transplantation. The ideal candidate will have previous submissions experience in either RA, CA or EC, as you will be involved in supporting these types of submissions.
One of the most exciting parts about the role is working the CRO itself, they pride themselves on their excellent reputation in the market and this is backed up with facts. They have a 95% annual retention rate of their staff, and have enjoyed a consistent 15% growth rate over the last decade. They are also well known for supporting the progression of their staff with around 20% globally being promoted annually, this is achieved through the structured mentoring program they have in place to help people achieve their goals.
- Conducting all types of visits: PSV, SIV, SMV/IMV, COV and completing the study visit deliverable within the relevant timelines and adhering to the guidelines of ICH-GCP, the study SOPs and relevant regulatory bodies
- Assist with SSU duties including feasibilities and site selection
- Collecting, review, and track essential documents
- Participating in client, investigator and project team meetings
- Performing site management activities and provide ongoing updates of site status to the CPM
- Conduct remote monitoring and complete duties outlined in the study specific monitoring plan
- Utilise systems and reports to track subject status, subject CRF retrieval and SDV regulatory documents, and IP
- Support in developments of CRF and monitoring plan when needed
- Provide support to the Regulatory Affairs/SSU team in preparation of document submission to EC, RA or CA and follow up the approval process, keeping communication with the sponsor
- Support in contract negotiation, investigator payments, and site payments
- Manage ISF and TMF for all assigned studies in line with SOPs and study specific monitoring plans
- Identify site issues and resolve
- Liaise with clinical data management team for data cleansing activities
Education and Qualifications
- Minimum of 4 years independent monitoring experience in Italy
- Experience of working within complex studies
- Exposure to EC, CA or RA submissions would be a bonus
- Must be based in Rome or 50km surrounding area
- Life Sciences degree
- Fluent in Italian & English
Please contact Harry Henson on email@example.com or +44 203 875 9966 for further information on the role!
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