Research Coordinator / Junior IRB Administrator
CHEManager International · San Diego, CA · 6 days ago
AnalystFull-time
Responsibilities
- Assist the NHRC IRB and HIPAA Privacy Office with processing research study submissions for compliance with DoD, Navy, and federal regulations, including Exempt, Expedited, and Full-Board (Initial, Continuing, and Modification) reviews.
- Draft routine communications such as approval letters, follow-up memos, and emails under supervision and in accordance with Navy, DoD, and DHHS guidelines.
- Help maintain accurate IRB records and meeting minutes to ensure compliance with human subject protection regulations.
- Support the organization of IRB documentation archives in both electronic and paper formats per DoD requirements.
- Assist with tracking training requirements, helping team members stay up to date, and providing technical assistance as needed.
- Maintain databases for Not Human Subject Research determinations and Data Use Agreements.
- Support the coordination and documentation during audits, especially related to HIPAA compliance.
- Demonstrate a basic understanding of federal regulations and ethical principles in human research protection.
Qualifications
- Bachelor's Degree in life sciences, public health, psychology, or related field.
- At least 1-2 years of relevant IRB experience, administrative support in research environments, or clinical research experience.
- Exposure to IRB submissions or related compliance/regulatory processes.
- Willingness to pursue IRB certification (e.g., CIP) if not already held.
- Familiarity with medical terminology, research documentation, or regulatory procedures.
- Strong written and verbal communication skills; ability to work with a diverse set of stakeholders.
- Ability to manage tasks independently, stay organized, and maintain attention to detail.
- Basic proficiency in Microsoft Office Suite and comfort with Windows-based systems.