Senior CRA

A global CRO is looking to hire experienced CRAs (CRA II or Senior CRAs) to join them on a permanent basis in Romania. These roles will be sponsor dedicated, you will work exclusively on one sponsors trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.

Working across therapeutic areas, the CRA will be 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.

Responsibilities:

• You will monitor multiple Phase I, II, III & IV clinical trial sites, across different therapeutic areas. Assist other CRAs with co-monitoring activities both remote and on-site.
• You will utilise your customer service mindset with your sites focusing on delivering value, building loyalty and trust to create a positive impact and strong relationship with investigators and study coordinators where respect, knowledge and commitment to ICH/GCP guidelines are key to successful trial conduct.
• As the CRA you are the main sponsor representative, providing key project updates. You will collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely.
• You will be first to review "source to CRF/eCRF," ensuring patient safety and data integrity aspect of the study.
• As the first point of contact for study sites, escalating any concerns/issues to other departments including Safety, Investigational Medicinal Product, Local Study Managers and management team as appropriate.
• Additionally, you will oversee the sites' adherence to GCP/ICH practices, ensuring quality of study conduct.

Role Requirements:

• Bachelor’s Degree (or equivalent)
• Minimum 1 year of independent on-site monitoring experience
• Ability to travel nationally 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

For additional information and a confidential discussion, please send a copy of your CV to trish@warmanobrien.com