CRA II or Senior CRA - Sponsor Dedicated (home based or office based)

CRA II or Senior CRA positions available to work within and international environment across different therapeutics areas and phases I, II and III. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites in Italy. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!

• Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets (6 per month)
• The role can be home based or office based in Italy.
• Join a stable team of CRAs and benefit from outstanding training and development, both initially and throughout your career
• Join a company where people tend to stay for 6-10 years rather than 1-3!
• Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance.
   

Responsibilities Include

As a CRA you will manage all aspects of study site monitoring according to SOPs, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

• All aspects of site management as prescribed in the project plans
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
• Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements
• Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
• Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems

• University/college degree or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology).
• Thorough knowledge of ICH guidelines, GCP and the clinical trial process
• Knowledge of the drug development process.
• Proficient computer skills with good working knowledge of a range of computer packages including Electronic CRF processes.
• Excellent verbal and written communication skills (local language and English)
• Valid Driver’s License
   

3-4 years of experience in a related field, including 2-3 years of independent on-site monitoring in CRO or Pharma

Experience with all trial Phases I-IV and PoC Studies

Preferred Locations Rome and Milan