Dublin (Hybrid model)
1 year fixed term
30th June 2022
Clinical Operations Lead
- Biological/ life sciences, pharmacy, chemistry and/or medical or nursing background.
- Minimum of one year clinical research experience or equivalent.
- 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 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 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 Clinical Operations Lead.
Cancer Trials Ireland welcomes applications from candidates seeking part-time working arrangements. In addition, Cancer Trials Ireland offers flexible/hybrid working arrangements for all vacancies.