Observational Research Specialist provides site management for observational/non-interventional research study sites in accordance with relevant SOPs, study specific procedures and regulations.
- Site identification
- Negotiation of site agreements and budgets
- Collection and review of regulatory documents for EC and RA submissions
- Customization of informed consent
- Site management.
The location will be either office-based or decentralised from Madrid.
- Primary contact for assigned sites
- Perform site start-up activities
- Demonstrate protocol expertise
- Conduct remote visits (initiation, monitoring, termination)
- Train team members on selected tasks
- Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC,IVRS, ISIS)
- Responsible for the completeness and quality of the in-house site specific files (in cooperation with ROA/RMA)
- Update all relevant tracking systems on an ongoing basis
- Follow-up on appropriate site related questions.
- Sound interpersonal, oral and written communication skills
- Strong computer skills including Clinical Trial Management Systems, Electronic records, EDC, MS-Office products such as Excel, Word and PowerPoint.
- Strong awareness of all relevant regulations, including GCP and GPP
- Ability to successfully work in a (‘virtual’) team environment
- Strong knowledge of observational/non-interventional study research
- Sound problem solving and analytical skills
- Strong customer focus, ability to interact professionally within a client organization and with study sites
- Willing and able to travel as required – local or international.
- Educated to degree level (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience.
- Fluency in Spanish, Portuguese and English is a must.
- Previous clinical monitoring (on-site or remote) data management and/ or research experience with a solid understanding of observational/non-interventional research methodology and terminology.
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