SEC Recruitment

(Senior) Clinical Research Associate - Sponsor Dedicated

Italy, Milan (province) / Rome (province), Italy
£43373.28 - £52409.38 per annum
12 Apr 2021
10 May 2021
Rebecca Law
Full Time
Contract Type
Experience Level
Experienced (non-manager)
I am currently seeking an individual to join a reputable CRO in a permanent, home based position as a sponsor dedicated Clinical Research Associate II / Senior Clinical Research Associate.

The Company

You will be working outsourced to a leading pharmaceutical company who have an extensive pipeline within Oncology, across both early and late stage development, as well as additional therapy areas such as Neurology and Infectious Diseases. You will be tasked with carrying out a mix of remote and on-site monitoring visits (largely remote due to the current climate) with scope to take on additional responsibilities, such as training and co-monitoring alongside junior CRA's, as your seniority level within the clinical monitoring team grows.

The Role

Main responsibilities include, but are not limited to;

* Completing site selection, pre-study start up activities and assisting in site evaluation
* Managing investigative site activity to ensure satisfactory study understanding and compliance of all site staff and providing updates to the Study Manager as necessary.
* Oversee study start-up or site management activities such as helping with regulatory submissions to Ethic Committees, contract negotiation and budget negotiation.
* Completion of monitoring reports and follow-up letters; including all key findings and recommendations for future actions.
* Maintaining Trial Master File (TMF)/electronic Trial Master File (eTMF).
* May provide training, mentoring, and co-monitoring alongside junior CRA's as required.

The Person
Requirements are as follows;

* Minimum 2 years independent, on-site monitoring experience.
* BSc in a Life Science related discipline (higher degrees very desirable).
* CRA Certification according to Ministerial Decree dated 15/11/2011.
* Experience as CRA/Clinical Monitor in CRO/Pharma/Biotech essential.
* Experience within oncology essential.
* Professional proficiency in both English and Italian.

This is a fantastic opportunity for anyone who is interested in working within the sponsor side of clinical trials whilst having the support of a reputable CRO who can offer competitive packages and development opportunities, to ensure you continue to grow within your career as a CRA. So, if you feel that you would be a good fit or you simply want to find out more about this role, then don't delay and apply today!

If this isn't the role for you but you know someone that would be suitable, tell them to drop me an email or give me a call, my contact details are below.

T: +44 (0)2072556620