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Responsibility For Protocol Expertise With Accountability For Quality And Timelines And The Following Site Start-up Activities Observational Research Specialist provides site management for observational/non-interventional research study sites in...
Responsibility For Protocol Expertise With Accountability For Quality And Timelines And The Following Site Start-up Activities

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.
In this role you will support studies in Spain and Portugal.

The location will be either office-based or decentralised from Madrid.

Key Accountabilities
  • 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.
Qualifications

Skills
  • 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.
Education
  • Educated to degree level (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience.
Language Skills
  • Fluency in Spanish, Portuguese and English is a must.
Minimum Work Experience
  • 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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