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Clinical Research Associate ( CRAII or Senior CRA) - Remote - Romania. ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently recruiting for experienced Clinical Research Associates in Romania to work on a range of therapeutic areas for a prestigious and global biopharmaceutical company. This particular CRA role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs. The Clinical Research Associate is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
Job Responsibility:
Monitor multiple Phase I, II, III & IV clinical trial sites, across different therapeutic areas
Assist other team members with co-monitoring activities both remote and on-site
Utilize customer service mindset with sites focusing on delivering value, building loyalty and trust
Act as the main sponsor representative, providing key project updates
Collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely
Act as the first point of contact for study sites, escalating any concerns/issues to other departments
Oversee the sites' adherence to GCP/ICH practices, ensuring quality of study conduct
Requirements:
Bachelor’s Degree (or equivalent)
Minimum 3.5 years of independent on-site monitoring experience/experience as a field CRA
Ability to travel with overnight stays
Experience conducting all types of MVs such as: Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site
A demonstrated working knowledge of ICH/GCP Guidelines
Excellent record-keeping skills and attention to detail
Fluent in English and Romanian, both written and oral
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license
What we offer:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments