Key Requirements1. 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.

• Monitor clinical trial sites for assigned studies under the supervision of the study manager or

senior team member in line with ICH-GCP, applicable regulatory requirements and guidelines,SOPs, study protocols and study-specific procedures.Primary Responsibilities

• Perform initiation, monitoring and close out site visits
• Prepare reports of 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) under the supervision of thestudy manager or senior team member.

• 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 staff members.

Meet regularly with the Clinical Project Manager/Trial Coordinator for assigned studies toreview/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.