19 Oct
ENGINEERINGUK
Montreal
Clinical Associate, Single-Sponsor (French-Speaking)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.
Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity.
We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
Role Summary: To be an integral part of the study team whilst acquiring clinical and corporate knowledge of clinical trial conduct. Provide administrative support to the Project Manager(s), Clinical Trial Manager(s), and/or sites, with emphasis on driving global inspection readiness.
The role:
1. MUST be fluent in French and English
2. To be an integral part of the study team whilst acquiring clinical and corporate knowledge of clinical trial conduct.
3. Provide administrative support to the Project Manager(s), Clinical Trial Manager(s) and/or sites, with emphasis on driving global inspection readiness.
4. Recognize, exemplify and adhere to ICON's values which center around our culture of accountability, integrity, partnership, collaboration and excellence in delivery.
5. This is a developmental role which requires extensive training.
An ability and willingness to travel (drive and fly) as needed for this role and at least 60% of the time for future roles is required.
6. To acquire knowledge of ICH GCP, the conduct of clinical trials and governing regulations, relevant ICON SOPs, ICON internal tracking systems and client SOPs / client systems (when applicable).
7. To assist the project teams with the set-up, organization and maintenance of clinical study documentation (e.g. Study Files, CRFs, etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archival.
8. To assist in the processing of Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study.
9.
To share responsibility in the quality control audits of clinical study documentation (e.g. Study Files, CRF Files, Monitoring Files, etc.) to ensure study files are inspection ready at all times.
10. To facilitate and coordinate ordering/dispatching and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies, and study binders) as appropriate.
11. To assist project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to study/client systems (as appropriate).
12. To run, review and analyze study reports for accuracy and work with the project teams to ensure updates are completed correctly.
13. To assist in coordination of site/ study related payments, if applicable.
14.
To contact and serve as a contact for clinical sites for basic requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
15. To assist in the tracking and distribution of safety reports.
16. To coordinate document translation, if required.
17. To assist with, and attend the Project team meetings, and corresponding activities preparation, generation of meeting minutes and agendas.
18. To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.
19. To assist with the coordination of various status and tracking reports including but not limited to team member tracking and training.
20. To work in collaboration with internal and external colleagues to meet project objectives and timelines.
21.
To keep the Project Manager / Project Director / Clinical Operations Designee informed of any issues within the Project Team which require attention.
22. To maintain client and patient confidentiality.
23. Other duties as assigned.
Associates degree in nursing. Bachelor's degree or local equivalent, in life sciences or related discipline.
Benefits of Working in ICON: Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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