Study Start Up CRA
ICON
Unknown, Unknown, Canada
Full-Time
$1,235
OfficeExecutive
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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 Manager
Collaborates 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 commitments
Accountable for timely start up activities from country allocation until site greenlight at assigned sites
Conducts site selection visits, 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-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 activities
Prepares and finalizes site specific documents for submission
Negotiates investigator payments, as needed
Supports, preparation of financial contracts between sponsor and investigational site sand investigators, as needed
Updates all systems until site Green Light on an ongoing basis
Supports preparation of audits and inspections, as applicable
Supports reduction of formal site specific IRB/IEC deficiencies
Ensures timelines, accuracy, and quality 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 aligned with the sponsor strategy
Ensures sites are prepared 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 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 2–3 years in Site Start-Up (SSU) activities.
Fluency in both French and English (written and verbal) is required.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON 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.
Are you a current ICON Employee? Please click here to apply