Founded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase. Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2023, and the Asia-Pacific Contract Research Organization Company of the Year Award since 2006. The Company offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech is a trusted end-to-end strategic partner of choice.
Our international clients value our enthusiastic, flexible and quality-focused professional approach to meeting their needs, and we are continuing to grow further. To support our future development, we are currently looking for a Clinical Research Associate.
Job summary: 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 clinical sites, maintaining study files, conducting pre-study and initiation visits, liaising 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 the Clinical Operations Manager, you will be a key member of the Clinical Operations team in Italy.
We are searching for an 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-cultural communication and cooperation and shall be significantly independent in their performance.
Main Tasks of the Position: 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 the supervisor. Responsible for monitoring clinical sites, maintaining study files, conducting pre-study initiation visits, regular visits, and close-out visits, assisting on audit/inspection visits, and assisting in the site and vendor contracting process, liaising 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. Required Qualifications, Experience, Competencies: At least 2-3 years of monitoring 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 and Italian. Computer skills. Benefits: Working with an experienced and very professional and supportive team. Possibility to grow within the Company. Competitive remuneration. Flexible working time. Eligibility to the Company Bonus scheme. Home-based/Office based.
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