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Observational Research Specialist II

4 months ago

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As an Observational Research Specialist II, you will independently provide site management and support activities for Observational/ Non-interventional research study sites in accordance with relevant Standard Operating Procedures (SOPs), study-specific procedures and regulations. This is a Canada home-based/REMOTE role


Key Accountabilities:

Depending on study assignment and with support as necessary key accountabilities can include:

  • Act as primary contact for assigned sites and build positive business relationships with physicians and site staff.
  • Site identification, selection and start-up activities including negotiation of site agreements and budgets.
  • Demonstrating protocol expertise.
  • Customization of country/site specific documentation.
  • Conducting of all remote and on-site monitoring activities through all study stages.
  • Proactive issue management with a focus on issue prevention.
  • Identification of potential out of scope activities.
  • Perform regular reviews of data according to Site Management Plan (SMP).
  • Responsible for the completeness and quality of the site files for the assigned sites.
  • Maintaining study management system(s) on a daily basis.
  • Regularly inform manager, ORL and PL (as needed) of status of work.
  • Maintain a working knowledge and ensure compliance with applicable Good Pharmacoepidemiology Practices (GPP) guidelines, local country requirements, SOPs and study specific procedures.


Skills:

  • Excellent interpersonal, verbal and written communication skills in English (and local language as necessary).
  • Excellent customer focus and able to interact professionally with a client organization and study site.
  • Strong computer skills, familiar with MS-Office products including Excel, Word and PowerPoint, Clinical Trial Management and EDC systems.
  • Thorough knowledge of Observational/ Non-interventional study research and relevant regulations including GPP.
  • Ability to work in a 'virtual' team environment as well as work independently, seeking guidance as appropriate.
  • Consistently delivers work to 'First Time Quality' whilst managing time effectively to meet metrics and/or team objectives.
  • Sound problem solving and analytical skills and able to prioritize multiple tasks and achieve study timelines.
  • Seeks opportunities to develop experience and knowledge making suggestions to enhance service delivery.
  • Willingness to travel LOCALLY and NATIONALLY up to 30% when necessary.


Knowledge and Experience:

  • Clinical Monitoring, Data Management and/or research experience with a solid understanding of Observational/ Non-interventional research methodology and terminology.
  • Fluent in French Language-speaking and writing REQUIRED.


Education:

  • Degree in a life science, nursing qualification or other relevant experience required.