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Clinical Research Regulatory Specialist
2 months ago
Regulatory Coordinator - Medix™
Location: Chicago, IL
Hours: Flexible, On-site
Compensation: $37.50/hour
Position Overview:
The Regulatory Coordinator plays a crucial role in overseeing and facilitating the review and approval processes for all research activities related to clinical studies involving human participants. This position is dedicated to ensuring the utmost protection of participant safety, rights, and welfare. The Coordinator interprets and applies relevant regulations while advising principal investigators (PIs) and research personnel on the preparation, submission, documentation, and reporting of study activities to maintain compliance.
Key Responsibilities:
- Interprets and applies relevant regulations governing clinical research involving human subjects, ensuring their safety and rights are prioritized. Coordinates all submission, documentation, and reporting processes, including new study applications, renewals, and amendments, while recommending alternatives to achieve compliance.
- Acts as a liaison among research personnel (PIs, faculty, nurses, technicians) and regulatory bodies (IRB, sponsors, government agencies) to address issues, negotiate solutions, and provide recommendations that facilitate research while ensuring adherence to regulations.
- Identifies required compliance documentation and drafts essential items such as protocols and informed consent forms. Ensures the accuracy of IRB approval letters in relation to sponsor details and grant identifiers.
- Offers guidance and training to research staff to promote compliance with complex regulations associated with clinical research involving human subjects.
- Generates reports, summaries, and analyses regarding compliance requirements, suggesting improvements in practices or procedures to enhance efficiency and effectiveness.
- Stays informed about new and updated regulations related to clinical research, alerting relevant staff to changes and ensuring proper interpretation and application to ongoing studies.
Additional duties may be assigned as necessary.
Minimum Qualifications:
- Completion of a four-year degree in a relevant field such as computer science or information technology, or an equivalent combination of education and experience.
- Familiarity with oncology terminology and an understanding of protocol design.
Essential Competencies:
- Strong knowledge of regulatory frameworks, including the Code of Federal Regulations and Good Clinical Practice Guidelines.
- Proficient in computer applications, including word processing and database management.
- Ability to collaborate effectively within a team environment.
Preferred Qualifications:
- CITI certification.
- At least one year of experience in research, clinical trials, or regulatory affairs.