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Study Start-Up - Clinical Research Associate (SSU CRA)

-Bulgaria based - Sponsor dedicated

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 development trials in the country. 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 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.
• 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.

Qualifications:

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 1 year of relevant experience in CRA and/or Study Start up role.
• Good knowledge of clinical research regulatory requirements.
• Knowledge on vendor management, investigator payments, contracts and site monitoring activities and processes.
• Attentive to details, good administrative and documentation processing skills.
• Written and verbal communication skills including good command of Bulgarian and 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.
• Available to occasionally travel and/or work from office, as per job requirements.

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