Senior Clinical Research Specialist

2 days ago

Cork, Cork, Ireland beBeeResearch Full time €60,000 - €80,000
Clinical Research Associate Role

This role involves designing, planning, implementing, and managing clinical research projects to ensure compliance with the protocol and overall clinical objectives as well as applicable standards and regulations.

  • Collaborate with cross-functional teams in planning, executing, and closing pre-market and post-market clinical studies.
  • Develop and approve study-specific documents, tools, presentations, and processes.
  • Maintain Trial Master Files and Investigator Site Files for multiple studies.
  • Prepare and present at Investigator meetings.
  • Participate in site qualification, study initiation, and study closure process.
  • Manage medical device tracking and accountability.
  • Create and maintain study databases, including data entry, reviewing data/CRFs to ensure integrity, accuracy, and protocol compliance.
  • Track and report progress of studies to internal stakeholders.
  • Develop study reports and provide clinical reports for regulatory submissions.
  • Perform monitoring and site visits, preparing site visit, data query, adverse event, and study deviation reports.
Key Requirements
  • Bachelor's degree in Science or a related field.
  • Minimum 4 years of experience in the medical device industry.
  • Experience in pre-market and post-market clinical studies of medical devices essential.
  • Clinical certifications desirable.
  • Thorough understanding and knowledge of ISO 13485, ISO 14155, ICH GCP, US 21CFR820, and EU MDR.
  • Proven track record in project management.
  • Strong problem-solving and communication skills.
  • Self-motivated, highly organized, and detail-oriented.

We are seeking an individual who can effectively contribute to our team's success by bringing their expertise and passion for clinical research to this role. If you have the required skills and qualifications, we encourage you to apply for this exciting opportunity.

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