Clinical Trials Expertise

2 weeks ago

Cork, Cork, Ireland beBeeClinicalTrial Full time €53,000 - €73,000
Clinical Trials Specialist

We are seeking a highly motivated and detail-oriented Clinical Trial Specialist to join our team. As a key member of our clinical development team, you will play a critical role in ensuring the successful start-up and maintenance of investigator sites for clinical trials.

Key Responsibilities:
  • Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, and tracking site compliance with required training.
  • 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 related to site start-up and maintenance.
  • Ensure country-specific regulatory and data privacy requirements are incorporated into submission documents and other 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.
  • Anticipate and monitor dynamically changing priorities.
Essential Qualifications:
  • Bachelor's degree preferably in a scientific or health-related field.
  • 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.

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