Study Start Up CRA

Job Overview

The Study StartUp CRA is accountable for site selections as well as studyspecific startup activities and deliverables of assigned sites for Phase IIV 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 CRA for all sites is key.

Responsibilities

• Supports country SSU strategy in close collaboration with the SSO Study StartUp Team Lead the SSO Study StartUp Manager and the SSO Feasibility Manager as well as the SSO Site Partnership Manager
• Collaborates with the SSO Study StartUp Manager the SSO Study StartUp Team Lead and global study team to ensure Study StartUp timelines and deliverables are met according to country commitments
• Accountable for timely startup 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 startup and IRB/IEC and HA submission preparation
• Ensures that milestones (KPIs) and time schedule for study startup are met as planned
• Facilitates the preparation and collection of site and country level documents
• Collects submissionrelated sitespecific documents for all relevant site personnel within agreed timelines (e.g. FD CV GCP certificates DSL etc.
• Supports the SSU Manager with preparation of countryspecific documents e.g. ICF patient facing materials etc.
• Supports the SSO Study StartUp Manager and assigned sites with vendor setup 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 sitespecific IRB/IEC deficiencies
• Ensures timelines accuracy and quality of country and site TMF documents in study startup 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 Sponsors strategy

Qualifications

• Bachelors Degree Degree in scientific discipline or health care preferred.
• Requires at least 2 years of onsite monitoring experience.
• Experience in startup 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 startup 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 problemsolving 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