Clinical Trials Associate - Romanian Speaker

The purpose of the Trial Capabilities Associate role for a company based in Cork, Ireland who is looking to grow their career in Clinical Trials.

*Native Romanian speaker with fluency in English is essential for this role.*

Responsibilities

• Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site's ERB and Competent Authority (CA) (where applicable), track and ensure site compliance to required training, and 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
• Identify, communicate, and resolve issues
• Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
• Leverage previous site / review board engagements to efficiently drive new work
• Populate internal systems to ensure accuracy of trial / site performance
• Understand and comply with procurements, legal and financial requirements and procedures
• Populate Trial Master Files and libraries for future reference
• Provide feedback and shared learning for continuous improvement
• Leverage trial prioritization
• Anticipate and monitor dynamically changing priorities

Qualification Requirements:

• Bachelor's degree preferably in a scientific or health related field
• One year experience working in clinical trials
• Understanding of the overall clinical development paradigm and the importance of efficient site activation
• Applied knowledge of project management processes and skills
• Appreciation of / experience in compliance-driven environment
• Effective communication, negotiation, and problem solving skills
• Self-management and organizational skills
• Native Romanian speaker with fluency in English is essential for this role.

Additional Preferences:

• Two years clinical research experience or relevant experience preferred