Clinical Research Associate Lead
Translational Research in Oncology
TRIO (Translational Research in Oncology) is a clinical research organization that is dedicated to advancing translational cancer research by pursuing forward, innovative, and targeted therapeutic concepts in the clinical trial setting. We are committed to providing treatments of the future to the world of today.
TRIO is seeking a CRA Lead (internally referred to as Monitoring Resources Coordinator) to join our international team, home-based in Ontario or Quebec, Canada. Our Monitoring Resource team plays a pivotal role in moving important research forward and helping to save cancer patientsâ€™ lives all over the world.
TRIOâ€™s head office is in Edmonton, Alberta with operations all throughout Canada, the USA, France and Uruguay. The main objective of the Monitoring Resources team is to effectively monitor TRIOâ€™s clinical trials with respect to contractual obligations and project deadlines according to the sponsor protocol and in compliance with the appropriate SOPs.
- Supervise assigned Clinical Research Associates (CRAs) to ensure monitoring activities are performed as per requirements (ICH GCPs, local regulatory requirements, TRIO SOPs, trial protocols, timelines and budget), for multiple trials.
- Oversee all trial-related monitoring activities performed by the CRAs.
- Compile monitoring metrics and key performance indicators for the CRAs.
- Communicate regularly on project status to the CRA Manager, Project Management and the Sponsor (if applicable) to ensure project goals are met.
- Proactively identify, escalate or resolve monitoring issues, as appropriate.
- Participate in the selection of internal and external CRAs.
- Coordinate site hand-over process between 2 CRAs as per TRIO or sponsor procedures
- Perform CRA assessment visits, as per TRIO SOP, as required.
- Responsible for ensuring timely site audit report reply (MR part). Responsible forimplementation of/ follow-up on corrective actions/preventive actions, when appropriate.
- Ensure timely follow-up on oversight visit findings by the CRAs.
- Prepare and conduct trial-specific calls for Third-Party Organization or TRIO CRAs within an assigned country.
- Participate in process improvement initiatives, as required.
- Bachelor's Degree in health fields such as Medical, Nursing, Pharmacy, or Health Science â€“ or its international equivalent.
- With a minimum of 5 years of experience in the field as a CRA, oncology knowledge is an asset
- Ability to assess, mentor and train CRAs in a positive and effective manner
- Excellent knowledge of medical terminology and clinical monitoring process
- Strong ICH-GCPs knowledge
- Ability to prioritize multiple tasks and achieve project timelines
- Must work both independently and in a team environment.
- Excellent verbal and written communication skills and attention to details with an ability to work in a multi-cultural environment
- Read, write and speak fluent English
- Ability to travel up to 30% on average
We thank all candidates for their interest; only those selected for an interview will be contacted.
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