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Paula O'Reilly
Life Science

+353 1 507 9265
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Details

Study Start Up Associate


Reference:POR207667 Location: Cork
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Research Associate

A Study Start Up Associate - Netherlands is required to join a leading global Pharmaceutical business based in Cork. In this role you will be responsible for obtaining clinical trial authorizations and ethical approvals,execution of the budget and contract, and activities related to clinical finance, records management and site training.

The Role

  • 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 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 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


The Person

  • Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred
  • Understanding of the overall clinical development paradigm and the importance of efficient site initiation
  • Fluency in English is essential
  • Fluency in Dutch is preferred
  • Applied knowledge of project management processes and skills
  • Appreciation of / experience in compliance-driven environment
  • Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
  • Effective communication, negotiation, and problem solving skills
  • Self-management and organizational skills