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