CRA, FSP - Oncology/Gen Med - Italy
- Experience Level
- Experienced (non-manager)
Here at Syneos Health Italy, we are looking for an experienced CRA (CRA II or Senior CRA) to work sponsor dedicated for one of our best partners in innovative Oncology or General Medicine trials. The job location could be any well connected city in Italy. We also offer up to 10000 € Sign On Bonus!
Why Syneos Health?
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. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites) for GCP compliance according to Syneos Health SOPs and/or client guidelines;
Recruit investigators for participation in clinical trials;
Negotiate study budgets with investigators;
Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites;
Review draft protocols for completeness and feasibility;
Develop Case Report Forms for clinical trials;
Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators’ Meetings;
Prepare and process Serious Adverse Event (SAE) reports;
Prepare project management reports for clients, project personnel, and Syneos Health management;
Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries;
Resolve queries of CRF data with study site personnel;
Review Tables and Listings generated from study data;
Assist in writing Clinical Study Reports;
Train junior CRAs on monitoring, internal procedures, and query resolution.
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience;
- Minimum 2 years of independent monitoring experience required;
- In possession of CRA Certification as per Ministerial Decree dated 15/11/2011;
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements;
- Must demonstrate good computer skills and be able to embrace new technologies;
- Excellent communication, presentation and interpersonal skills;
- Ability to manage required travel of up to 50% on a regular basis.
We offer a highly competitive remuneration and package.
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.