Observational Research Specialist II

1 month ago

Quebec, Canada Parexel Full time

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.

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.
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