Ref #: 27535

Employment type: Permanent - Full-Time

Location: Italy

Posted: 09-Mar-2021

Description

Here at DOCS Global, we've entered into a partnership to supply an additional full-time, permanent home-based Independent CRAs to be aligned with a top-10 multinational pharmaceutical and biopharmaceutical company.

You will need to be well-versed in the role of an Independent CRA, including experience of independent monitoring visits, SIVs and Close-Out Visits.

What is Offered;
* Excellent Salary package
* Permanent career opportunity, including extensive training period.
* Home-based flexibility

The Role and your Responsibilities;

* 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;

What is Required;

* Degree (BA/BS/BSc) in life sciences or qualified nurse preferable
* At least 12/18 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 clinical trial set up and contract negotiation preferred, but not essential
* EDC working experience
* Full-time availability

Contact Mattia.Carcangiu@docsglobal.com to discuss in more detail.

Why join the DOCS team at ICON?

Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.

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