|Job title :||CRA II/Senior CRA - Orphan Diseases & Advanced Therapies|
|Location :||Milan, Milan (province)|
|Job type :||Permanent|
|Salary :||£50000 - £60000 per annum + Car allowance, bonus, benefits.|
|Contact name :||Sam Doherty|
|Contact email :||email@example.com|
Office based, Milan (with home working flexibility)
A niche CRO specialising in the delivery of clinical trials within complex therapeutic areas, rare diseases/orphan indications and ATMP with an established Italian presence is currently seeking an experienced CRA II or Senior CRA to take on the management, monitoring and set-up of Italian sites, with average travel of around 6 days on site each month outside of pandemic conditions.
- Perform monitoring visits in accordance with the monitoring plan, ICH-GCP guidelines, company SOP's and any other regulatory requirements.
- Build strong relationships with site staff and investigators.
- Act as a mentor and role model to more junior CRA's and team members where applicable (potentially including accompanied site visits/co-monitoring).
- Conduct study set-up activities including ethics submissions, local regulatory submissions, and R&D applications.
- Participate in investigator meetings where required.
- May also assume Lead CRA responsibilities for certain studies as assigned (reviewing reports, international coordination etc).
- At least 2 years' independent monitoring experience, with complex study experience required.
- A minimum of a Bachelor's degree in a life science subject (equivalent Nursing or Healthcare qualification also acceptable).
- Any previous experience performing IRB/Ethics submissions would be preferred for the "Senior CRA" level but not essential.
- Solid knowledge of ICH-GCP guidelines.
This is a fantastic opportunity with an extremely competitive remunerations package and salary, as well as a great deal of autonomy and the chance to carry out a far more varied role than what any of the larger CRO's can offer within a close-knit team.
You can apply for this role by e-mailing your CV to Sam.Doherty@secpharma.com or telephoning +44 (0) 207 255 6665.
Keywords: CRA, Clinical Research Associate, CRA II, Clinical Research Associate II, Senior CRA, Senior Clinical Research Associate, UK, Lead CRA, Lead Clinical Research Associate, CRA III, Clinical Research Associate III