Junior Clinical Research Associate

Cancer Trials Ireland; Dublin; On-site; EUR 45,000 - 65,000; Full time

Job summary

Cancer Trials Ireland is seeking a professional with a Biological/ life sciences or related background to perform site initiation, monitoring and related trial activities in Ireland. The role requires at least one year of clinical research experience or equivalent and involves maintaining essential regulatory documents, preparing study materials, and coordinating with investigators and Sponsor teams.

You will monitor sites, ensure compliance with SOPs and guidelines, and contribute to audits and

Qualifications

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

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 (Patient Information Leaflets, Informed Consent Forms, Protocols, Case Report Forms) under supervision.

Skills

Biological sciences

Pharmacy background

Medical background

Job description

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Application Details

In order to work in Ireland a non-EEA National, unless they are exempted, must hold a valid employment permit. Please review the Eligibility and requirements for an employment permit if you are unsure of your eligibility to apply for this vacancy.

Job Description

Key Requirements

• Biological/ life sciences, pharmacy, chemistry and/or medical or nursing background.
• 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 orsenior 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 issuesas 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/orSponsor 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.

• This vacancy is suitable for Remote/Blended working
• Sector: professional, scientific and technical activities

Career Level

• Experienced [Non-Managerial]