Compliance Specialist
Há 2 dias
Job Opportunity:
As a primary point of contact, the Senior Regulatory Specialist will coordinate with investigative sites during site start-up and maintenance activities. This role requires collecting required documents to ensure timely submissions to regulatory authorities, ensuring documentation meets applicable regulations and sponsor specifications.
Key Responsibilities:
- Maintain awareness of current regulatory standards related to submissions in assigned countries.
- Coordinate, collect, and organize data required by regulatory authorities, including preparation of study documentation.
- Liaise with internal and external vendors regarding regulatory authority submissions.
- Perform a review of final submission documents.
- Ensure all start-up and maintenance activities are on track, compliant with laws and guidelines, and meet client expectations.
- Prevent and escalate study issues as necessary.
- In country-specific tasks: serve as primary contact for investigative sites, collect and track required documents, and perform quality reviews.
Requirements:
- University/College degree (life science preferred), or certification in a related allied health profession from an accredited institution, and 2 years' work experience in clinical research.
- Familiarity with ICH guidelines, RA, IRB/IEC regulations, and investigator start-up documents.
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