CRA II/Senior CRA - Orphan Diseases & Advanced Therapies

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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 :
(Senior) Clinical Research Associate - Orphan Indications/Rare Diseases
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.

Key Responsibilities:

- 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).

Key Requirements:

- 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 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