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Position: Clinical Trial Assistant (CTA)
You'll have training and development to plan and progress your career in the direction you choose.
And you won't do it alone - you will have been supported a experienced mentor.
We offer great opportunities for a career in world-leading clinical research.
Clinical Trial Assistant Responsibilities:
- Assistance of Clinical Research Associates (CRAs) and Regulatory Officer in preparation of regulatory dossier for submission to EC and CA
- Assist CRAs with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines;
- Assist the clinical team in the preparation, handling, distribution, filing and archiving of clinical documentation and reports according to the scope of work and standard operating procedures;
- Communication with investigators , authorities, sponsors on behalf of CRA in respect to all study related issues delegated to CTA by CRA
- Assistance of CRA's in study related tasks
- Translation of documents, letters, etc. from/into English
- Performing assigned administrative tasks to support trial team members
Qualifications and Experiences for both positions:
- Education:
A Bachelor's degree in a health care or other scientific discipline or educational equivalent
- Experience:
Previous experience in a similar role at least two years, either in a pharmaceutical company or a CRO is a plus.
- Skills:
- Effective communication, organizational, and interpersonal skills
- Ability to work independently and to effectively prioritize tasks
- Ability to manage multiple projects
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Knowledge of applicable regulatory requirements, SOPs and company's Corporate Standards
- Understanding of regulated clinical trial environment and knowledge of drug development process
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Perfect PC and Microsoft Office (Outlook, Word, Excel, PowerPoint) knowledges
- Language:
- Fluent English language. Demonstrated analytical and report writing skills.
Only candidates meeting the above requirements are requested to apply.
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