As a Clinical Research Associate you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study, initiation visits, regular visits and close out visits and liaison with vendors and other duties. You will function as the primary contact for sites regarding regulatory compliance and protocol questions and communicate with clinical sites on an ongoing basis to address and resolve issues. Reporting to Clinical Operations Manager, you will be a key member of the Clinical Operations team in Italy.
We are searching for ambitious and energetic person, able to undertake challenges in the project, push forward development of the project and function well in the project team. The desired person shall be open to cross cultures communication and cooperation and shall be significantly independent in their performance.
Minimum Qualifications & Experience:
• Excellent knowledge of the clinical trial process and ICH/GCP and local requirements/ guidelines
• Excellent organizational and time management skills
• Skills to handle multiple priorities and to work with deadlines and under pressure
• Excellent written and oral communication skills
• Skills to coach and mentor other clinical staff
• Fluent in written and verbal English & Italian
Job Responsibilities:
• Responsible for recruitment of potential investigators, involvement in CA and EC submissions and notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
• Responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study initiation visits, regular visits and close out visits, assists on audit/inspection visits and assists in site and vendor contracting process, liaison with vendors and other duties
• Functions as the primary contact for sites regarding regulatory compliance and protocol questions and communicates with clinical sites on an ongoing basis to address and resolve issues;
• Assists in Business Development activities
• May have supervisory functions in clinical projects
• May be required to train, coach and supervise junior staff
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
