Lead compliance programs for IESO ensuring adherence to regulations while supporting business and stakeholder engagement in electricity sector.
About the role
- Regulatory coordinator overseeing various industry, Federal, and Foundation clinical trials. Facilitating compliance, documentation, and safety reporting processes in support of healthcare research.
Responsibilities
- Performs study specific regulatory and safety reporting processes across multiple studies in accordance with appropriate regulations
- May oversee work of junior staff and train or mentor others in compliance
- Prepares FDA regulatory submissions in collaboration with ORAQ
- Addresses FDA review and hold issues in collaboration with the Principal Investigator
- Maintains study level documentation for international studies
- Prepares for support study monitoring and audit visits
- Identifies all AEs, determines reportable nature, collaborates with PI
- Develops consent plans and documents for participants
- Communicates with IRB staff and reviewers
- Enters and collects data, develops data entry or collection SOPs
- Develops reports on study progress for the PI and collaborators
Requirements
- Completion of an Associate's degree
- Work requires a minimum of two years of research and regulatory experience
- Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience
- A Bachelor's degree may substitute for 2 years required experience
- Regulatory experience is preferred
Benefits
- Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status.
- Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
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