Clinical Research Associate/CRA II

Location
Dublin (Hybrid model)
Contract Type
Permanent Full-time
Closing Date
18th February 2022

Reports to:
Clinical Operations Lead

Key Requirements

  1. Biological/ life sciences, pharmacy, chemistry and/or medical or nursing background.
  2. Minimum of one year clinical research experience or equivalent.

Main Function(s)

  • 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.

Primary Responsibilities

  • Perform activities according to Cancer Trials Ireland and/or Sponsor SOPs (if applicable).
  • 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, Cancer Trials Ireland and/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 at Cancer Trials Ireland and/or with Sponsor (if applicable) and 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.
  • Perform other tasks as specified by COM.