Clinical Research Associate II or Senior CRA

University Positions; Lyon; Hybride; EUR 40 000 - 80 000; Plein temps

Résumé du poste

Ein etabliertes Unternehmen im Bereich klinische Forschung sucht einen Clinical Research Associate, der in einem dynamischen Umfeld arbeitet. In dieser Rolle sind Sie für die Verwaltung von Prüferstandorten verantwortlich, planen und führen Site Visits durch und stellen die Einhaltung der ICH-GCP-Richtlinien sicher. Das Unternehmen bietet eine wettbewerbsfähige Vergütung und ein unterstützendes Arbeitsumfeld, in dem Ihre Beiträge geschätzt werden. Wenn Sie eine Leidenschaft für die klinische Forschung haben und in einem Team arbeiten möchten, das sich der Verbesserung der Lebensqualität widmet, ist dies die perfekte Gelegenheit für Sie.

Prestations

Wettbewerbsfähige Gehälter

Jährliche Boni

Gesundheitsleistungen

Rentenpläne

Lebensversicherung

Qualifications

• Mindestens 18 Monate Erfahrung als CRA in Phase I-III-Studien.
• Vorherige Erfahrung in der Überwachung von mittelgroßen Studien.

Responsabilités

• Verantwortung für die Verwaltung von Prüferstandorten bis zum Abschluss.
• Planung und Durchführung von Standortbesuchen gemäß dem klinischen Überwachungsplan.

Connaissances

Monitoring Erfahrung in klinischen Studien

Kenntnisse der ICH-GCP-Richtlinien

Exzellente Kommunikationsfähigkeiten in Englisch und Französisch

Fähigkeit, unter Druck zu arbeiten

Description du poste

Location : Office based (Paris or Lyon) or Home based

Employment Status : Permanent

Department : Global Large Pharma

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.

As a Clinical Research Associate at ICON, you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV, ensuring adherence to applicable regulations and principles of ICH-GCP.

The role :

• Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site right through to close-out.
• Planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan.
• Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
• Preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues.
• Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines.
• Potential to assist in training and mentoring fellow CRAs.

You will be operating as a key part of a global study team and playing a fundamental role in our clients’ drug development processes.

You will need :

• 18 months+ of monitoring experience in phase I-III trials as a CRA.
• Previous monitoring experience in medium-sized studies, including study start-up and close-out.
• Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data.
• Excellent written and verbal communication in English and French.
• Ability to work to tight deadlines.
• Availability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driving license.

Benefits of Working in ICON :

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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 through the form below.