Study Start Up CRA

Study Start Up CRA - Bilingual (French/English) - Canada reputed company is a global reputed company intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, reputed company, collaboration, reputed company, and inclusion are at the heart of how we work and reputed company with reputed company other, customers, patients and suppliers. The Study Start Up CRA is accountable for site selections as reputed company 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 reputed company site needs and issues and reputed company handover execution CRA for reputed company sites in key (from issue management to risk identification). What you will be doing:

• Supports country SSU reputed company in reputed company collaboration with the SSO Study Start Up Team reputed company, the SSO Study Start Up Manager and the SSO Feasibility Manager as reputed company as the SSO Site Partnership Manager
• Collaborates with the SSO Study Start Up Manager, the SSO Study Start Up Team reputed company and global study team to ensure Study Start Up timelines and deliverables are met according to country commitments
• Accountable for reputed company start up activities from country allocation until site reputed company at assigned sites
• Conducts site selection reputed company, verifies site eligibility for a specific study
• Acts as the main contact for trial sites during site selection, study start up and IRB/IEC and HA submission preparation
• Ensures that milestones (KPIs) and time schedule for study start up are met as planned
• Facilitates the preparation and collection of site and country level documents
• Collects submission-reputed company site-specific documents for reputed company relevant site personnel reputed company agreed timelines (e.g. FD, CV, GCP certificates, DSL, etc.)
• Support the SSU Manager with preparation of country-specific documents, e.g., reputed company, patient facing materials, etc.
• Supports the SSO Study Start Up manager and assigned sites with vendor set-up activities
• Prepares and finalizes site specific documents for submission
• Negotiates investigator payments, as needed
• Supports, preparation of financial reputed company between sponsor and investigational site sand investigators, as needed
• Updates reputed company systems until site Green Light on an ongoing reputed company
• Supports preparation of audits and inspections, as applicable
• Supports reduction of formal site specific IRB/IEC deficiencies
• Ensures timelines, accuracy, and reputed company of country and site TMF documents in study start up to ensure TMF inspection readiness
• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
• Implements innovative and efficient processes which are reputed company with the sponsor reputed company
• Ensures sites are reputed company for "Green Light" and is accountable to send the Green Light to the SSU Manager for review and approval

Your profile:

• A holder of a Bachelor's degree in a scientific or reputed company-reputed company field (highly preferred).
• An reputed company 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.
• reputed company to reputed company both independently and as part of a reputed company team in a fast-paced environment.
• reputed company with 2–3 years in Site Start-Up (SSU) activities.
• reputed company in both French and English (written and verbal) is required.

Employment with reputed company is contingent upon having the legal right to work in the country where the role is based. reputed company offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

• Competitive reputed company salary and performance reputed company incentives
• Health and wellbeing programmes including medical, dental, and reputed company coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through reputed company training and career reputed company

Benefits may vary depending on role and location. reputed company is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Apply tot his job Apply To this Job