Clinical Trials Specialist

2 weeks ago

Cork, Cork, Ireland beBeeClinical Full time €45,000 - €56,000

We are a global healthcare leader that gives our best effort to our work and puts people first.

Role Purpose:

The purpose of this role is to provide clinical trial capabilities in support of clinical development. The associate is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out.

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), 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

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