SSU CRA - Hungary - One sponsor dedicated

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

Sponsor dedicated, less travelling

CRA 1- Sr CRA 1 level

Overview:

The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables 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 to this role.

Accountabilities:

• Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team to ensure timelines and deliverables are met.
• 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 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.
• 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.
• 1-5 years of relevant experience in CRA and 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 Hungarian and English language.
• Organizational and problem-solving skills.