Ref #: 30781

Employment type: Permanent - Full-Time

Location: Italy

Posted: 19-Jul-2021

Description

Do you have clinical trial monitoring experience of phase II-III Oncology studies?
Do you love monitoring and being an active part within drug development?

Then look further, this is the role for you!

Our client is looking to recruit an experienced CRA who can demonstrate strong Oncology clinical trial monitoring of phase II-III studies within the industry.


What is Offered:

* Full-time
* Permanent career opportunity
* Home based role

The Role:

* To perform all aspects of CRA duties from site selection, site initiation, through to site routine monitoring visits through to close-out visits and database lock.
* Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.);
*Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks as instructed by the PM;
* Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;
* Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports;
* Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports;
*Communicates effectively with site personnel, including the Principal Investigator (PI), and company management to relay protocol/study deviations and ensure timely implementation of corrective actions;


To be successful in the role, you will have:

* Degree (BA/BS/BSc) in life sciences or qualified nurse
* At least 24 months 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 Oncology external/independent clinical monitoring of phase II-III clinical trials preferred (other therapeutic areas could be considered)
*Experience of clinical trial set up and contract negotiation preferred, but not essential
*Experience in Oncology is preferred
*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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