***LOCATION: CORK, IRELAND (Funded relocation)

Permanent role based on a hybrid model

Salary up to EUR 55k/year + 5% annual bonus

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), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain a fully-executed contract, 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, 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

Basic Qualifications:

• Bachelor’s degree preferably in a scientific or health-related field
• 2 years of clinical research/clinical trials/regulatory affairs/pharmacy experience or similar relevant experience
• Fluency in both English and Romanian
• Understanding of overall clinical development paradigm and the importance of efficient site initiation
• Applied knowledge of project management processes and skills
• Appreciation of / experience in a compliance-driven environment
• Ability to learn and comply with financial and legal guidelines and policies (budget and contract)