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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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