Senior Study Coordinator - CHUM – Gastroenterology Department - Montreal
(2022-07)
- Conduct patient pre-screening, screening and informed consent in compliance with GCP
- Perform study visits, follow-up visits and ensure accurate and timely data entry
- Lead regulatory submissions to the Ethics Committee (NAGANO)
- Program and manage REDCap databases for internal research projects
- Coordinate pharmaceutical and institutional studies, including international multicenter trials
- Manage site initiation visits (SIVs): preparation of training slides, presentations and investigator materials
- SIV conduction
- Oversee site training, monitor data entry quality and protocol compliance
- Assume team leadership responsibilities and manage study activities during colleague absence
- Coordinate and supervise students and junior staff
- Manage installation and implementation of AI-based medical devices in endoscopy rooms
- Provide leadership for multiple concurrent institutional studies across multicenter sites in Canada and the United States
- Ensure billing and reconciliation processes, as well as budget negotiations
Clinical Research Assistant - CHUM – Breast Cancer Research Group - Montreal
(2021-12 - 2022-04)
- Supported initial clinical trial set-up (drug ordering, lab kits, logistics, shipping)
- Coordinated with multiple hospital departments (pharmacy, radiology, laboratory, pathology, etc.)
- Ensured compliance with consenting, screening and eligibility procedures
- Managed patient randomization and communication with sponsors
- Completed eCRFs using Oracle, Rave and Orchid, ensuring data accuracy and quality
- Developed study-specific tools and worksheets to support protocol implementation
- Maintained compliance with SOPs, protocols, GCP and regulatory requirements
- Reported adverse events and serious adverse events within required timelines
- Participated in site initiation, monitoring and close-out visits
- Prepared studies for monitoring visits and audits
- Processed and shipped biological samples in accordance with TDG regulations
- Trained new staff and translated study documents when required
Study Coordinator - CHUM – Oncology & Hematology Research Group - Montreal
(2020-04 - 2021-12)
- Created source documents in accordance with study protocols
- Prepared purchase orders for study visits using Dynacom
- Coordinated site initiation, monitoring and close-out visits
- Completed electronic and paper CRFs
- Assisted clinical nurses during study visits
Clinical Research Associate - JSS Medical Research - Saint-Laurent, QC
(2019-04 - 2020-03)
- Created, updated and maintained Trial Master Files (TMF)
- Managed protocol submissions to Ethics Committees
- Coordinated team allocation and training compliance
- Managed site payments and distribution of study materials
Study Coordinator - European Hospital Georges Pompidou - Paris, France
(2016-04 - 2019-01)
- Recruited patients and scheduled study visits and protocol-required examinations
- Performed data entry within Sponsor deadlines
- Organized site initiation and monitoring visits
- Prepared PowerPoint presentations for investigative teams
- Collected and analyzed data for retrospective studies
- Completed feasibility questionnaires
Sales Associate (Part-time) - Kiabi - France
(2013-07 - 2015-08)
- Customer service and sales support
- Cash handling and store organization
