* 업무 내용
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
* 자격요건
1. Education Requirements- Bachelor’s degree (Health related)
- Master’s 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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