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Clinical Trial Assistant (CTA)

SanaClis
3 года назад
23 ноября 2020
Киевул. Бориспольский р-н., с.Пролиски, ул. Соборна, 18

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.

 

Тамара

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