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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Research Coordinator Medical Devices


Reference:SCAYUN-071632 Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Clinical Research Coordinator Medical Devices
Our client, an innovative medical device company are currently recruiting for aClinical Research Coordinator to join their team on a permanent basis. As Clinical Research Coordinator you will be focused on designing, planning, implementing, and managing the overall conduct, or particular elements, of clinical research projects. You will ensure compliance with the protocol and overall clinical objectives as well as applicable Standard Operating Procedures (SOPs) and regulations. This role is offering hybrid working.


Responsibilities

  • Coordinate the activities of interdisciplinary team members in the planning, executing and closing of clinical studies
  • Develop and approve study-specific documents, tools, presentations and processes
  • Deliver study related training
  • Select and co-ordinating Trial Management Committee and Steering Committees, when applicable
  • Prepare and present at Investigator meetings
  • Participate in the site qualification, study initiation and study closure process
  • Assist with the management of medical device distribution, receipt, use and return of products used during clinical studies
  • 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, enrolment, data collection, adverse event documentation and reporting
  • Develop Study Reports and provide clinical reports for Regulatory submissions
  • Assist in query writing and resolution process
  • Identify and gather missing or incomplete data from investigational sites
  • Conduct site visits, as necessary
  • Act as a company liaison to work with clinical sites, Contract Research Organizations (CROs) and other vendors
  • Conduct site monitoring visits, writing visit reports
  • Manage non-compliance for resolution and prevention
  • Budget forecasting and payment approvals
  • Maintain familiarity with all applicable regulatory requirements and relevant clinical literature
  • Maintain compliance with ISO 13485 QMS, ICH GCP, MDR, Declaration of Helsinki, Data Protection Act and any other clinical study/trial regulations
  • Carrying out activities related to QMS documentation control, as required
Requirements
  • Bachelor’s degree in Science or related disciplines with a minimum of 4 years of experience in a medical device company
  • Certified and maintain certification in GCP Training
  • Strong ability to manage critical projects as part of an interdisciplinary team
  • Excellent problem solving and communication skills
  • Must be self-motivated, highly organised, and detail-oriented
  • Excellent oral and written communication skills
  • Familiar with regulatory and/or completed regulatory courses
  • Must be able to work as part of a cross functional team
  • Thrives to work in a fast-paced / entrepreneurial environment

For more information contact Sinéad Cullen on +353879500821 or [email protected]