Senior Clinical Research Associate

1 mese fa

Italia ENGINEERINGUK A tempo pieno

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role:

  • 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.
  • 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.

To be successful in the role, you will have:

  • Degree (BA/BS/BSc) in life sciences or qualified nurse preferable.
  • Minimum 2 years of independent CRA monitoring experience is mandatory.
  • Experience of clinical trial set up and contract negotiation preferred, but not essential.
  • EDC working experience.
  • Full-time availability.

Please note that for the role the Italian Certification as per DM 15/2011 is required.

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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