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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Research Associate II (CRA II)


Reference:SCANWM-263405 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

Clinical Research Associate II (CRA II)

Our Dublin based client are currently recruiting for a Clinical Research Associate II (CRA II) to join their team on a permanent basis.


Responsibilities

  • Maintain knowledge of ICH-GCP, applicable regulatory requirements and guidelines, SOPs (Standard Operating Procedures), study protocols and study-specific procedures
  • Co-ordination of clinical trial activities for assigned studies in line with ICH-GCP, applicable regulatory requirements and guidelines, SOPs, study protocols and study-specific procedures
  • Perform activities according to the organisations or Sponsor SOPs
  • Perform site visits for every stage of a clinical trial- investigator and site selection visits; initiation; monitoring; close out
  • Prepare reports of site selection, initiation, monitoring and close-out visits and follow-up on
  • outstanding issues as per the study monitoring plan
  • Perform monitoring and reconciliation of Serious Adverse Events (SAEs)
  • Collect and maintain essential documents as required by ICH-GCP, or Sponsor SOPs and regulatory requirements/ethics committees
  • Prepare and review study related documentation as applicable (Patient Information Leaflets, Informed Consent Forms, Protocols, Case Report Forms and others)
  • Prepare Regulatory Authority and Ethics Committee submissions if required
  • Communicate on study issues internally with Investigator and site staff
  • Track clinical trial activities
  • Assist with training, mentoring and development of new and junior CRAs
  • Meet regularly with the Clinical Project Manager/Trial Coordinator for assigned studies to review/update on the status of studies regularly and upon request
  • Input into SOP development where appropriate
  • Contribute to preparation for audits and inspections as required
  • Organise and attend Investigator meetings if applicable
  • Prepare and make presentations as required

Requirements
  • Biological/ life sciences, pharmacy, chemistry and/or medical or nursing background
  • Minimum of two years clinical research experience or equivalent