Clinical Trials Capabilities Assistant Fluent Romanian

Clinical Trial Capabilities Assistant Fluent Romanian
Our client, a global pharmaceutical organisation based in Cork are currently recruiting for a Clinical Trial Capabilities Assistant to join their team on a permanent basis. Fluent Romanian and English is a requirement for this role. As Clinical Trial Capabilities Assistant you will provide technical support to the clinical trial capabilities team in support of clinical development. You will be responsible for activities related to investigator sites readiness, maintenance and close out, ensure inspection readiness through a complete, accurate and readily available Trial Master File.

Responsibilities

• Initiate investigator site activities, including collection and submission of regulatory documents
• Track and ensure site compliance to effectively drive timelines aligned with company priorities
• Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
• Support TPO and investigator payments as appropriate
• Manage site account requests
• Invoice query resolutions
• Identify, communicate, and resolve issues
• Accountable for accurate and complete data entry of clinical trial information into various clinical trial systems to allow tracking, performance metrics reporting and to meet regulatory compliance requirements
• Ensure appropriate archiving of documents to meet record retention polices and regulatory requirements

• Fluent in English and Romanian are essential for this role
• Applied knowledge of project management processes and skills
• Appreciation of / experience in compliance-driven environment
• Ability to learn and comply with regulatory requirements and internal policies
• Effective communication, teamwork and problem solving skills
• Very good attention to details and accuracy
• Self-management and organizational skills
• Excellent computer skills