Study Start Up CRA

Job Overview

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.

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.)
• 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's strategy

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience.
• Experience in start-up activities from country allocation until site greenlight at assigned sites, in conducting site selection visits, verifies site eligibility for a specific study and in acting as the main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Fluent in written and verbal communication in Arabic including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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