Senior Clinical Research Associate - Remote - Italy

An international contract research organisation (CRO) is recruiting for a Senior Clinical Research Associate (SCRA) to join their Italian team. The company provides complete professional services for the clinical research and development of pharmaceutical compounds, medical devices and diagnostic tests in the areas of oncology and life-threatening diseases and conducts studies which lead to marketing approval of significant medical advances. This is an exciting opportunity to work with a firm that has built a reputation on assuring the scientific objectivity and meticulous quality control that fulfils all regulatory requirements. The position will be with the company's Milan team, but in a home-based capacity.

Job Responsibilities:

• Our CRA's conduct on-site monitoring visits according to the Study Monitoring Plan which includes:
• pre-study
• initiation
• routine
• Studying closeout/completion visits and telephone contacts for our oncology clinical trials.
• Reviewing patient/subject Informed Consent Process and documents.
• Drafting monitoring visit reports and follow-up letters within study specific time-frames.

Skills and Requirements:

• CRA Certification according to Ministerial Degree DM 15.11.2011.
• Bachelor degree preferably in biological or life sciences curriculum.
• Must have 5 years or more of on-site monitoring (as a CRA) experience involving Phase I and II global oncology protocols working for a Sponsor and/or CRO.
• Prior experience monitoring first-time-in-human (FTH) studies is highly desirable but not required.
• Must thoroughly know current GCP/ICH guidelines, and have a strong understanding of oncology monitoring and monitoring-processes (i.e. RECIST).
• Clinical Research (I.T.) Systems Experience.
• Familiarity with Research Site (hospital) Electronic Medical Records (EMR) systems (i.e. EPIC).
• 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 Valeria Cardo at +44 203 854 0674 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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