CLINICAL RESEARCH ASSOCIATE (CRA)

Descrizione dell'offerta

Johnson & Johnson is an American multinational company founded in 1886, a world leader in the development of products and devices for surgical therapies and pharmaceutical companies, as well as in the marketing of consumer products for personal hygiene, and is organized into three business segments: Pharmaceutical, Medical & Diagnostic, Consumer. Every day more than 120,000 employees work in 250 companies of the Group, located in 60 countries. In Italy there are all the three sectors, each of which represents one of the segments mentioned above:

Janssen SpA (Pharmaceutical Sector):

Marketing Company: Milan Plant: Borgo San Michele (Latina)

Johnson & Johnson SpA (Consumer Sector):

Marketing Company and Plant: Santa Palomba (Rome)

Johnson & Johnson Medical SPA (Medical and Diagnostic Sector):

Marketing Company: Pratica di Mare (Rome).

Janssen-Cilag SpA is looking for a Clinical Research Associate (CRA) , to be hired with a Permanent Contract in the Clinical Operation Team. The CRA is the person in Trial Co-ordination and Site Management that serves as primary contact point between the sponsor and the investigational site.

A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock.

THE FIGURE WILL BE RESPOSIBLE FOR:

· Acting as primary local company contact for assigned sites for specific trials;
· Attending in investigator meeting;
· Being responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close - out according to internal Standard Operating Procedures (SOP), Work Instructions (WI) and policies;
· Ensuring site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases;
· Ensuring that all adverse events /Serious adverse events /Product Quality Complain are reported within the required reporting timelines and documented as appropriate;
· Maintaining complete, accurate and timely data and essential documents in system utilized for trial management;
· Collaborating with Local Trial Manager for documenting and communicating site/study progress and issues to trial central team;
· Attending regularly scheduled team meeting and trainings;
· Working closely with Local Trial manager to unsure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types

Profilo richiesto

Qualifications :


Academic & Professional Background: University Degree in Science.
Experience: A minimum of 2 years as CRA
Language Knowledge: Fluent in English
IT Knowledge: Good Office knowledge (MS Word, MS Excel, MS Power point) and SAP.

The figure will be located in Cologno Monzese.