Clinical Research Project Coordinator

3 days ago

Cork, Cork, Ireland beBeeResearch Full time €60,000 - €90,000

Job Overview

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As a key member of our interdisciplinary team, you will play a pivotal role in designing, planning, implementing, and managing the overall conduct of clinical research projects. Your primary objective will be to ensure compliance with the protocol and overall clinical objectives as well as applicable regulatory requirements.

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Key Responsibilities:

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  • Assist in the planning, execution, and closure of pre-market and post-market clinical studies;">
  • Develop and approve study-specific documents, tools, presentations, and processes;">
  • Prepare ethics submissions and study-specific documents such as protocols, patient information leaflets, informed consent forms, and case report forms;">
  • Maintain Trial Master Files and Investigator Site Files for multiple studies;">
  • Prepare and present at Investigator meetings;">
  • Participate in the site qualification, study initiation, and study closure process;">
  • Assist with the management of medical device tracking and accountability;">
  • Create and maintain study databases, including data entry, routinely reviewing data/CRFs to ensure data integrity, accuracy, and protocol compliance;">
  • Track and report progress of studies to applicable internal stakeholders, including patient screening, enrollment, data collection, adverse event documentation, and reporting;">
  • Develop study reports and provide clinical reports for regulatory submissions;">
  • Perform monitoring and site visits, including preparation of site visit, data query, adverse event, and study deviation reports;">
  • Act as a liaison to work with clinical sites, Contract Research Organizations (CROs), Site Management Organizations (SMOs), and other vendors/consultants;">
  • Maintain familiarity with all applicable regulatory requirements and relevant clinical literature;">
  • Maintain compliance with ISO 13485, ISO 14155, ICH GCP, EU MDR, US 21CFR820, Declaration of Helsinki, Data Protection Act, and any other clinical study/trial regulations;">
  • Carry out other clinical-related duties as required.">

Required Skills and Qualifications:

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  • Bachelor's degree in Science or related disciplines;">
  • 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 with the ability to successfully manage projects to deadlines;">
  • Strong ability to manage critical projects as part of an interdisciplinary team;">
  • Excellent problem-solving and communication skills;">
  • Must be self-motivated, highly organized, and detail-oriented;">
  • Excellent oral and written communication skills;">
  • Must be able to work as part of a cross-functional team;">
  • Thrives in a fast-paced/entrepreneurial environment.">

Benefits:

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Competitive salary, bonus, pension, healthcare, and excellent opportunity to develop your experience and career in an exciting company.

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