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Clinical Research Associate (CRA)

SanaClis
2 года назад
11 мая 2021
Киевул. вулиця Соборна, 18, Проліски, Київська обл., 08322

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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