Job Title

The Study Start Up CRA is accountable for site selections as well as study specific start up activities and deliverables of assigned sites for Phase I-IV trials in the country in accordance with monitoring procedures and processes following ICH.GCP, local regulations and SOPs Proactive site preparation and early identification of real site needs and issues and close handover execution CRA for all sites in key (from issue management to risk identification).What you will be doing:Supports country SSU strategy in close collaboration with the SSO Study Start Up Team Lead, the SSO Study Start Up Manager and the SSO Feasibility Manager as well as the SSO Site Partnership ManagerCollaborates with the SSO Study Start Up Manager, the SSO Study Start Up Team Lead and global study team to ensure Study Start Up timelines and deliverables are met according to country commitmentsAccountable for timely start up activities from country allocation until site greenlight at assigned sitesConducts site selection visits, verifies site eligibility for a specific studyActs as the main contact for trial sites during site selection, study start up and IRB/IEC and HA submission preparationEnsures that milestones (KPIs) and time schedule for study start up are met as plannedFacilitates the preparation and collection of site and country level documentsCollects submission-related site-specific documents for all relevant site personnel within agreed timelines (e.g. FD, CV, GCP certificates, DSL, etc.)Support the SSU Manager with preparation of country-specific documents, e.g., ICF, patient facing materials, etc.Supports the SSO Study Start Up manager and assigned sites with vendor set-up activitiesPrepares and finalizes site specific documents for submissionNegotiates investigator payments, as neededSupports, preparation of financial contracts between sponsor and investigational site sand investigators, as neededUpdates all systems until site Green Light on an ongoing basisSupports preparation of audits and inspections, as applicableSupports reduction of formal site specific IRB/IEC deficienciesEnsures timelines, accuracy, and quality of country and site TMF documents in study start up to ensure TMF inspection readinessEnsures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirementsImplements innovative and efficient processes which are aligned with the sponsor strategyEnsures sites are prepared for Green Light and is accountable to send the Green Light to the SSU Manager for review and approvalYou are: A holder of a Bachelor's degree in a scientific or healthcare-related field (highly preferred).An experienced Clinical Research Associate with a minimum of 2 years of on-site monitoring experience.Knowledgeable in clinical trial processes, regulatory requirements, and ICH-GCP guidelines.Detail-oriented with strong organizational and communication skills.Able to thrive both independently and as part of a collaborative team in a fast-paced environment.Experienced with 23 years in Site Start-Up (SSU) activities.Fluent in both French and English (bilingual required).Willing and able to travel 2030% across the country.