Study Start-Up CRA job opportunity at IQVIA Holdings, Inc..

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IQVIA Holdings, Inc. Study Start-Up CRA
Experience: 2-years
Pattern: full-time
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loacation Singapore, Singapore
loacation Singapore....Singapore

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

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