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Cra Ii, Italian and English Speaking

vor 4 Monaten

Home Office, Schweiz ICON Vollzeit

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.

ICON is working with one of the most successful global biotechnology companies to help them develop new medicines in critical areas to improve health and quality of life around the world. To achieve this, we are currently looking for a Clinical Monitor/Clinical Research Associate I-III (M/F/d) in Austria in a home office setting.

Primary responsibilities include:
Planning studies.
- Participate in the identification of new clinical trial sites; analyze opportunities and assist CRMA and CSM in making recommendations for trial enrollment.
- Assume an ambassadorial role to facilitate communication between study sites and the Novartis CPO to increase the value proposition for investigators.
- Facilitate site and country level document preparation and collection during all phases of the study. Assist the CSM with oversight of the Country and Site Trial Master Files (TMF). During all phases of the clinical trial, ensures archiving in accordance with relevant SOP.

Study start-up
- Conduct briefing and training of the study site, prepare the report of the familiarization visit.

Conduct of the study
- Perform full site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with the protocol, GCP, global and local regulations, and global and local processes.
- Identify site issues; resolve issues and escalate as appropriate.
- Complete preparation and generation of visit monitoring reports in accordance with relevant SOP.
- Review and manage site data; resolve technical and content issues on an ongoing basis to meet timely lockdown objectives.
- When working with central CRAs (blinded and unblinded) respond to alerts and follow up to ensure resolution of issues.

Closure of the study
- Perform study closure activities and prepare final report.
- Provide feedback on study site performance for feasibility/selection of future study sites.

To successfully fill the position you should have the following:

- Scientific background/similar with a minimum of 1 year experience as a CRA.
- The ability to travel 50% of the time
- Knowledge of local regulations and ICH/GCP guidelines
- Fluency in written and spoken English as well as Italian
- Familiarity with the risk-based monitoring approach
- Experience in conducting site selection, initiation, routine monitoring and close out visits both remotely (if applicable in the region) and onsite

What is offered
- Work for one of the world's top two CROs, sponsor specific in one of the world's leading pharmaceutical companies, fully integrated and from the sponsor's perspective
- Permanent contract,
- Home office when not traveling
- Excellent career opportunities

Sounds like you would be a great fit? Get in touch with me today

**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.