Here at Syneos Health, we are looking for a CRA II/Senior CRA to work sponsor dedicated to a top Pharma working in General Medicine trials. The candidate must be based in the Northern part of Italy.


Why us?

Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

Main responsibilities include:

• Assist in managing large scale clinical trial projects or function as project manager for small-scale projects, ensuring on time, on-budget performance
• Monitor investigator sites for GCP compliance according to Syneos Health SOPs and/or client guidelines
• Recruit investigators
• Negotiate study budgets with investigators
• Obtain, review, and process regulatory and administrative documents from investigator sites
• Review and develop protocols and CRFs
• Coordinate and present at Investigators’ Meetings
• Participate in proposal meetings with potential clients
• Prepare and review Serious Adverse Event (SAE) reports
• Prepare project management reports for clients, project personnel, and Syneos Health management
• Resolve issues, questions, and requests for additional study supplies
• Review and approve monitoring trip reports, review and verify completed CRFs, clinical data, Tables and Listings generated from study data
• Train and mentor CRAs on monitoring, internal procedures, and query resolution
• When allocated by study management, submit essential/required documents to a central IRB or a country’s central Ethics Committee, and, if necessary based on local requirements, the Competent Authority.  

 The ideal candidate will need the following experience / skills to be considered:

• Bachelor’s Degree in life sciences;

• Minimum 4 years’ experience in field monitoring for Sr CRA, min. 2 years for CRA II;

• Excellent organizational skills;

• Ability to manage time and work independently;

• Excellent written and oral communication skills.


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Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.