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Precision for Medicine, a Clinical Research Organization, is seeking a Regulatory and Start Up Specialist to join their team in South Korea. This role is crucial for ensuring the timely and quality delivery of site activation readiness.Responsibilities:
- Preparing Clinical Trial Application Forms and submission dossiers.
- Interacting with Competent Authorities (CA) and Ethics Committees (EC).
- Providing regular updates on CA and EC submissions.
- Maintaining project plans and regulatory intelligence tools.
- Developing study-specific start-up plans and essential document review criteria.
- Partnering with site CRAs to ensure alignment in communication.
- Customizing Patient Information Sheets and Informed Consent Forms.
- Coordinating document translations.
- Maintaining communication with various functions (Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts).
- Acting as SME for site-level critical path data.
- Supporting budget negotiations and investigator contracts.
- Participating in site outreach to assess investigator interest.
- Keeping updated on local clinical trial laws and regulations.
- Maintaining audit/inspection readiness.
- Supporting clinical team in Pre-Study Site Visits.
- Bachelor’s degree in life sciences or related field.
- 1+ year as a Regulatory or SU specialist in a CRO or pharmaceutical/biotech industry.
- Strong communication and organizational skills.
- Experience with computerized information systems, spreadsheets, word processing, and email.
- Fluency in English.
- Opportunity to work remotely.
- Chance to contribute to groundbreaking cancer therapies.
- A supportive environment where ideas are valued.
Precision for Medicine
Precision for Medicine is dedicated to enhancing clinical research and development. They achieve this by providing specialized services that integrate scientific understanding with advanced analytical platforms. They help optimize clinical trials, accelerate drug development, and enable a deeper understanding of disease mechanisms, ultimately aiming to improve patient outcomes through precision medicine approaches and tailored therapeutics.