Clinical Research Associate II 

Key Requirements

1.  Biological/ life sciences, pharmacy, chemistry and/or medical or nursing background.

2.  A minimum of 2 years as a CRA, preferably monitoring in Ireland

3. Oncology experience required

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 selection visits; study initiations; monitoring and close out visits according to the study monitoring plan.
• Prepare reports of site selection, initiation, monitoring and close-out visits and follow-up on outstanding issues according to the timelines specified.
• Collect and maintain essential documents as required by ICH-GCP, Cancer Trials Ireland and/or Sponsor SOPs.
• Preparation and review of study related documentation as applicable (Patient Information Leaflets, Informed Consent Forms, Protocols, Case Report Forms and others).
• Assist with preparation of Regulatory Authority and Ethics Committee submissions if required.
• Monitoring and reconciliation of Serious Adverse Events (SAEs).
• Tracking of clinical trial activities.
• Identification and communication of scientific misconduct.

Depending on your level of experience, you may also be given the opportunity to mentor junior members of staff, participate in the organisation and running of the CRA forum and also become a coordinator for one of our disease specific sub-groups.