CRA II, Sponsor Dedicated - Italy
- Experience Level
- Experienced (non-manager)
Here at Syneos Health, we are looking for a CRA II to work sponsor dedicated to a top Pharma. The role will be regionalised in the Norther part of Italy, so the ideal locations will be in Lombardia, Piemonte, Emilia Romagna and Veneto.
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.
• Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders;
• Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials;
• Develop Site relationships (incl. Contract Research Organization related issue management and non- registrational /Investigator Sponsored Research Studies);
• Recommends sites during the site feasibility and/or site selection process;
• Conducts pre-study visit as appropriate;
• Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation;
• Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, Sponsor's procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable;
• While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions;
• Serve as a point of contact for Sites;
• Provides trainings to sites;
• Performs site closure activities when all required protocol visits and follow-up are completed;
• Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory;
• Ensures completeness and quality of data submitted from study sites. Ensures eCRF data is available and current by using the available systems to follow site activities;
• Oversees activities of site personnel over whom there is no direct authority;
• Motivates/influences the site to meet study objectives, including enrollment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method;
• Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented;
• Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions;
• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner;
• May support Ethics Committee submission, ICF review, collection of documents to/from site;
• May support ensuring access to eDC and sponsor / vendor systems is available for clinical trial site personnel;
• May support equipment calibration and tracking;
• May support preparation of Study Initiation Visit materials;
• May support coordination and ensure database lock timelines are met as required locally.
• Bachelor's or Master's degree in Life Sciences or equivalent required;
• In possession of a valid CRA Certification according to the 15/11/2011 Ministerial Decree;
• 2 years experience in monitoring clinical trials;
• Has basic to good knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials;
• Experience in the drug discovery/development process;
• Knowledge and understanding of clinical research processes, regulations and methodology;
• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management;
• Organization and time management skills;
• Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations;
• Fluent Italian and strong English (oral & written);
• Computer/system proficiency;
• Strong/Excellent Interpersonal/ relationship skills.
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.