Study Start Up CRA

ICON plc • Blue Bell, SD

2d

About The Position

Clinical Research Associate (Study Start Up) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development 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

Requirements

• 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.

Responsibilities

• 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

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees