Join to apply for the Junior CRA/CRA1 role at Cancer Trials Ireland.
Key Requirements:
* Biological/life sciences, pharmacy, chemistry and/or medical or nursing background.
* Minimum of one year clinical research experience or equivalent.
Main Functions:
* Maintain knowledge of ICH-GCP, applicable regulatory requirements and guidelines, SOPs, study protocols and study-specific procedures.
* Monitor clinical trial sites for assigned studies under supervision, ensuring compliance with all relevant guidelines and protocols.
Primary Responsibilities:
* Perform initiation, monitoring, and close-out site visits.
* Prepare reports and follow-up on issues as per the monitoring plan.
* Monitor and reconcile Serious Adverse Events (SAEs).
* Collect and maintain essential documents per ICH-GCP, Cancer Trials Ireland, and sponsor SOPs and regulations.
* Prepare and review study documentation such as Patient Information Leaflets, Informed Consent Forms, Protocols, and Case Report Forms.
* Communicate study issues internally and with external stakeholders.
* Track clinical trial activities and assist with training and mentoring staff.
* Regularly review study status with the Clinical Project Manager/Trial Coordinator.
* Contribute to SOP development and prepare for audits and inspections.
* Organize and attend Investigator meetings, prepare presentations, and perform other tasks as assigned.
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