CRA II/ Senior CRA - Italy

A leading global contract research organisation is seeking to recruit a CRA II/Senior CRA - Italy. The company provides comprehensive, integrated drug development, laboratory, and lifecycle management services, working with partners across pharmaceutical, biotechnology, medical device, academic, and government organizations. This is an exciting opportunity to work with a company that has offices in 48 countries and more than 20,000 professionals worldwide, with a commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.

Job Responsibilities:

• Performing and coordinating all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations, and company SOP's.
• Monitoring investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification).
• Conducting 6-8 visits on average per month.
• Documenting observations in reports and letters in a timely manner using approved business writing standards.
• Escalating observed deficiencies and issues to clinical management expeditiously, presenting potential solutions, and following all issues through to resolution
• Ensuring that data will pass international quality assurance audits.
• Mentoring junior CRAs and performing co-monitoring visits.
• Managing the essential documents as required by local regulations and ICH GCP, before, during, and after a clinical trial.
• Representing the company in the global medical research community, developing and maintaining collaborative relationships with investigational sites.

Skills and Requirements:

• Bachelor's degree in a life-sciences related field.
• At least 3 years of independent monitoring experience as a CRA.
• Experience across a variety of therapeutic areas, any experience in Oncology, Cardiovascular, Gastro, or CNS advantageous.
• Certified according to Italian CRA Decree.
• Valid driver's license where applicable.
• Proven clinical monitoring skills.
• Demonstrable understanding of medical/therapeutic area knowledge and medical terminology.
• Demonstrable ability to attain and maintain a working knowledge of GCP's and applicable SOPs.
• Good oral and written communication skills in Italian and English.
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Theodora Savlovschi - Wicks at +44 203 752 0314 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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