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.
What you will be doing :
- Contribute to the identification of new sites for clinical trials
- Assume ambassadorial role to facilitate communication between sites and sponsor CPO to increase value proposition to investigators.
- Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the Clinical Study Manager in the oversight of Country and Site Trial Master Files (TMF).
During all phases of the trial ensure archiving per relevant SOP.
- Execute site initiation and training, generate initiation visit report.
- Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
- Identify problems at sites; resolve issues and escalate as appropriate.
- Complete preparation and generation of visit monitoring reports as per relevant SOP.
- Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
- Implement site close-out activities and generate site close-out report.
- Provide feedback on site performance for future trial site feasibility / selection
- Improve skills by timely completion performance of assigned global and local training.
You are :
- Bachelor’s Degree or higher in life sciences or equivalent
- Minimum 2 years’ clinical site monitoring experience from CRO or Pharmaceutical company OR a strong background as a Clinical Research Coordinator (3 years minimum) focused in oncology
- Comprehensive knowledge and understanding of ICH-GCP
- Able and willing to travel up to 60% regionally (Western Canada)
- Able and willing to work on several protocols / therapy areas
- Experience in phase I-IV trials
- Working knowledge of Electronic Data Capture (preferred)
- Experience / working knowledge of the oncology disease area (preferred but not required)
- Experience of Centralized / Risk Based / Targeted monitoring (preferred)
- Experience of working within a metric based environment (preferred)
- Excellent attention to detail
- Highly developed time management and organizational skills
- Focused on meeting study deliverables / targets
- Flexible and willing to adapt to changing priorities / timelines
- Experience in oncology is required
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