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2 mesi fa
About EastHORN Clinical Services
EastHORN Clinical Services 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, EastHORN Clinical Services has received numerous prestigious awards, including the CRO Leadership Award, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence, and the Asia-Pacific Contract Research Organization Company of the Year Award.
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, EastHORN Clinical Services is a trusted end-to-end strategic partner of choice.
Job Summary:
We are seeking an ambitious and energetic Clinical Research Associate to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. The successful candidate will be responsible for monitoring clinical sites, maintaining study files, conducting pre-study and initiation visits, liaising with vendors, and other duties. As the primary contact for sites regarding regulatory compliance and protocol questions, the candidate will communicate with clinical sites on an ongoing basis to address and resolve issues.
Main Responsibilities:
- Recruit potential investigators, involve in CA and EC submissions, and notifications to regulatory authorities.
- Monitor clinical sites, maintain study files, conduct pre-study initiation visits, regular visits, and close-out visits.
- Assist on audit/inspection visits, assist in the site and vendor contracting process, liaise with vendors, and other duties.
- Function as the primary contact for sites regarding regulatory compliance and protocol questions.
- Communicate with clinical sites on an ongoing basis to address and resolve issues.
- Assist in Business Development activities.
- May have supervisory functions in clinical projects.
- May be required to train, coach, and supervise junior staff.
Requirements:
- 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.
What We Offer:
- 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.
