Romanian Clinical Trials Associate – Cork.

Job Title: Romanian Clinical Trial Start-Up Associate in the Trial Capabilities Team

Location: Cork, Ireland

Permanent, full-time employment contract, hybrid working model with 50% attendance onsite

Salary: €45k-€55k DOE + 5% annual bonus

Relocation assistance provided: home finding assistance + 2K bonus taxed and paid extra to the first payment + 2 weeks’ short hotel accommodation provided by the client

Benefits: Life Assurance (4 x Annual Salary), Immediate & Comprehensive Medical Insurance for you & your closest dependent family (children, spouse), Pension Scheme, Educational Assistance Scheme (after passing the probation period and only if related to the position), Strong Work/Life Balance 37.5hrs p/w (No W/E or evening Work)

Job Overview

The Trial Capabilities Team provides essential support for clinical trial execution and clinical development. The Clinical Trial Start-Up Associate is responsible for ensuring investigator sites are ready to enrol participants and for supporting ongoing site activities during maintenance and close-out. This includes obtaining regulatory approvals, executing budgets and contracts, managing trial records, and coordinating site training. The Associate ensures inspection readiness with a complete, accurate, and accessible Trial Master File. Local responsibilities may vary based on geography or regional requirements.

Key Responsibilities

• Initiate and manage investigator site activities, including:
• Collecting and submitting regulatory documents
• Customising and negotiating informed consent documents
• Serving as the main contact for Ethics Review Boards (ERB) and Competent Authorities (CA), if applicable
• Communicating and negotiating budgets with sites and internal teams
• Obtaining fully executed contracts
• Tracking site training compliance and ensuring timelines are met
• Maintain ongoing collaboration with sites throughout study maintenance and close-out
• Identify, communicate, and resolve issues effectively
• Ensure all submissions and documents comply with country-specific regulatory and data privacy requirements
• Leverage previous site and review board experience to streamline new processes
• Update internal systems to accurately reflect trial and site performance
• Comply with procurement, legal, and financial policies and procedures
• Maintain and organize Trial Master Files and reference libraries
• Provide feedback for continuous improvement and knowledge sharing
• Anticipate and adapt to changing priorities in alignment with company objectives

Qualifications

• Bachelor’s degree in a scientific or health-related field
• Minimum of 2 years of clinical research or related experience preferred
• Strong understanding of clinical development and site initiation processes
• Native Romanian speaker with fluency in English
• Applied knowledge of project management principles
• Experience in compliance-driven environments
• Ability to learn and adhere to financial and legal guidelines (budget and contract management)
• Strong communication, negotiation, problem-solving, and organizational skills
• Self-motivated with the ability to manage multiple priorities independently