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4 тижні тому - 29.01.2021

Clinical Research Associate (CRA)

SanaClis

Адрес: Київ, вулиця Соборна, 18, Проліски, Київська обл., 08322
Контакт: Тамара

SanaClis is the company, focused on using data and science to help healthcare clients find better solutions for their patients.

SanaClis offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

If you want to continue your career as a CRA, this role is an ideal stepping-stone.

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 dedicated mentoring and receive reviews on performance and promotion.

SanaClis'll gives you access to cutting-edge in-house technology, allowing you to work on global projects but with a regional / home state travel remit.

You'll be building a smart and flexible career with no limits.

SanaClis offers great opportunities for a career in world-leading clinical research.

Join us on our exciting journey of clinical research!

Your typical responsibilities might include:

  • Performing feasibility, site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
  • Supporting the development of a subject recruitment plan
  • Establishing regular lines of communication plus administering protocol and related study training to assigned sites
  • Evaluating the quality and integrity of site practices - escalating quality issues as appropriate
  • Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
  • ICF adaptation
  • Contract negotiation with assigned sites and payment maintenance
  • Documents translation from/into English
  • Ensuring of accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.

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 one-two years, either in a pharmaceutical company or a CRO is a plus.
  • Successful at least three months of direct on-site monitoring experience is a plus.
  • Alternatively, you should have an equivalent combination of education, training and experience

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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