Ref #: 31288

Employment type: Permanent - Full-Time

Location: Italy

Posted: 30-Jul-2021

Description

The Role:
*Study Planning:
• Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.
• Assume ambassadorial role to facilitate communication between sites and the Client CPO to increase value proposition to investigators.
• Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
• Negotiate investigator remuneration; prepare financial contracts between Novartis and investigational sites and investigators. Ensure adherence to payment schedule.
*Study Start-up:
• Execute site initiation and training, generate initiation visit report.
*Study Execution
• Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
• Identify problems at sites; resolve issues and escalate as appropriate.
• Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
• Complete preparation and generation of visit monitoring reports as per relevant SOP
• Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
• If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues
*Study Close-out
• Implement site close-out activities and generate site close-out report.
• Provide feedback on site performance for future trial site feasibility/selection

*General
Improve skills by timely completion performance of assigned global and local training

To be successful in the role, you will have:

* Degree (BA/BS/BSc) in life sciences or qualified nurse preferable
* At least 2 years CRA experience gained within the industry as a Clinical Research Associate (CRA) either in Clinical Research Organisation (CRO) or pharmaceutical industry or investigational site
* Experience of clinical trial set up and contract negotiation preferred, but not essential
* EDC working experience
* Full-time availability

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.


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