Regulatory Affairs Study Start Up Specialist II
HybridSeoul, Seoul, South Korea
Job Summary
Assist project teams with regulatory requirements for clinical studies, including compliance assessments, document reviews, and IRB/EC submissions. Process study documentation from sites, interact with personnel for corrections, and compile Regulatory documentation according to CTI and sponsor SOPs. Prepare Clinical Trial Application forms, adapt Informed Consent Forms, and respond to Deficiency Letters from regulatory bodies. Manage sites budgets and contracts, oversee document translations, and support audit preparations. Provide periodic status reports, upload documentation to study start-up modules, and handle review, reconciliation, and archiving of study or project documentation.
Required Qualifications
- Associate's or Bachelor's degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
- A minimum of 3 - 5 years of relevant pharmaceutical, site, or CRO Regulatory experience
- Detail oriented
- Ability to collaborate well in a team environment
- Ability to maintain confidentiality
- Proficient in use of computer and software systems
- Excellent verbal and written communication skills
- Fluent in oral and written English
- Ability to provide superior level of customer service
- Ability to develop, prioritize, organize, and manage multiple tasks
- Strong decision making and creative problem-solving skills
- Strong understanding and application of principles, concepts, practices, and standards of the CRO industry
- Working knowledge and understanding of applicable country regulations, International Council on Harmonization (ICH) / Good Clinical Practice (GCP) regulations and guidelines
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