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Observational Research Specialist II (French- speaking)Job ID R0000003482 Canada, Remote
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Given the unique requirements of observational research, we utilize specialized clinical staff trained in observational-research processes as site managers for these studies. ORSs are assigned to work on a one-to-one basis with their sites, developing strong relationships with site staff, and optimizing study performance overall. In this way, sites each have a single resource to rely on throughout the study. This dedicated-staff model utilizes expertise in site engagement and customer service to make the experience of participating in an observational study a positive one for healthcare providers and patients. We consider this to be the optimal for the management of observational research studies, where customer service and adaptability are key.
The ORS is responsible for the site relationship and participation beginning with site recruitment, through site management and to close-out, and will coordinate any on-site monitoring activities as required.
- Depending on study assignment and with support as necessary key accountabilities can include:
- 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.
- Demonstrate protocol expertise.
- Customization of country/site specific documentation.
- Conduct 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.
- Maintain 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.
- 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.
- Willing to travel locally and internationally as necessary.
- Seeks opportunities to develop experience and knowledge making suggestions to enhance service delivery.
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 for speaking/writing
- Degree in a life science, nursing qualification or other relevant experience required.
This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.
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