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.
Key Roles & Responsibilities
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
1. Education Requirements
Bachelorโs degree (Health related) Masterโs degree or equivalent is preferred
2. Related Field Work Experience
2+ years of IRB-related 1+ year(s) of IACUC-related is preferred
3. Technical and Professional Skills / Knowledge
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
4. Key Competency
Accuracy Systematic way of thinking Transparent communication Commitment to Continuous Learning
5. Language Proficiency
Good English communication skill is required
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