IRB​/IACUC Administrative Assistant; IRB​/IACUC Department Seoul

We are seeking an IRB/IACUC Administrative Assistant for a 1-year-contract position to work within the IRB/IACUC Department
at the International Vaccine Institute in Seoul, Korea. (Duty station: Seoul, Korea)

Job Description

This job is responsible for assisting process, review, and finalizing approval of research protocols that involve human subjects and animals to ensure the protection of research participants and welfare of animal.

1. IRB/IACUC application review & management

• Assist in reviewing and analyzing applications including protocol, consent forms and all additional submitted documents to ensure completeness and compliance with appropriate international guidelines, institutional policies, and IRB/IACUC SOPs
• Assist in preparing, maintaining, and distributing the materials required for IRB/IACUC review
• Assist in notifying review result to investigators along with each due dates
• Assist in maintaining study files and associated records and documentation
• Assist in preparation for the IRB Full Board Meeting and IACUC Full Committee Meeting and all associated subcommittee meetings and internal discussions
• Assist in developing and maintaining e-IRB/IACUC system/website

2. IRB/IACUC member management & support

• Assist in maintaining required information about members for regulatory compliance
• Assist in maintaining records of the contributions of members operation of the IRB/IACUC

3. IRB/IACUC Quality Assurance/Improvement

• Assist in maintaining IRB/IACUC database on submission requirements/reminder items/awaiting receipts
• Assist in preparation for the FERCAP recognition, Korean Ministry of Health evaluation
• Assist in preparation for the MFDS/QIA inspection
• Assist in preparation for the monthly reminder for the IRB/IACUC study expiration dates and response due dates

4. IRB/IACUC related training

• Assist in developing, conducting, and managing formal and informal training program related to the IRB/IACUC

Job Requirements and Qualifications

• Bachelor’s degree (Health related)
• Master’s degree or equivalent is preferred

• 2+ years of IRB-related
• 1+ year(s) of IACUC-related is preferred

• Excellent knowledge of GCP, international guidelines, and law/regulation in relation to research ethics and clinical research
• Strong analytical skills
• Proficiency in the use of the MS Office

• Accuracy
• Systematic way of thinking
• Transparent communication
• Commitment to Continuous Learning
• Good English communication skill is required

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