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 to execution CRA for all sites is key (from issue management to risk identification).
Accountabilities
Supports country SSU strategy in close collaboration with the Study Start-Up Team Lead, the Study Start-Up Manager, and the Feasibility Manager as well as the Site Partnership Manager
Collaborates with the Study Start-Up Manager, the 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 Site Ops FSP Operations Manual
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.)
Supports 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 sites and 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
Qualifications and requirements:
University degree in scientific discipline or healthcare
At least 2 year of on-site monitoring / study start-up experience
Good knowledge of GCP and clinical research regulatory requirements
Good computer skills including MS Office
Excellent command of English language
Organizational, time management and problem-solving skills
Ability to establish and maintain effective working relationships with colleagues, managers, and customers.
Flexibility to travel.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
