Study Start-Up CRA

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.

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