Clinical Research Regulatory Coordinator

Welcome to Orlando Health, where we are dedicated to providing exceptional patient care and advancing medical research. We are currently seeking a highly organized and detail-oriented Clinical Research Regulatory Coordinator to join our team. In this role, you will play a crucial role in ensuring that our clinical research studies comply with all regulatory requirements and guidelines. If you have a passion for research and a strong understanding of regulatory processes, we encourage you to apply. Join us in making a positive impact on the future of healthcare.

1. Review and interpret regulatory guidelines and protocols to ensure compliance with applicable laws, regulations, and institutional policies.
2. Serve as the main point of contact for all regulatory inquiries and communications with external agencies, sponsors, and internal stakeholders.
3. Prepare and submit regulatory submissions, including but not limited to, Institutional Review Board (IRB) applications, amendments, and annual reports.
4. Maintain and update regulatory files and databases, ensuring accuracy and completeness of all documentation.
5. Collaborate with study teams and principal investigators to develop and maintain study-specific regulatory documents, such as informed consent forms and study protocols.
6. Conduct regular audits and reviews of regulatory documents to ensure ongoing compliance with regulatory requirements.
7. Stay informed and up-to-date on changes in regulations and guidelines related to clinical research and communicate relevant updates to the study team.
8. Coordinate and facilitate site visits and audits by regulatory agencies or sponsors.
9. Provide guidance and training to study team members on regulatory requirements and best practices.
10. Act as a liaison between the study team and regulatory agencies, effectively communicating any issues or concerns related to regulatory compliance.
11. Participate in the development and implementation of standard operating procedures related to regulatory compliance.
12. Maintain confidentiality and adhere to ethical standards in handling sensitive information and data.
13. Contribute to the development and maintenance of a culture of compliance within the organization.
14. Continuously monitor and evaluate processes and procedures to improve efficiency and effectiveness in meeting regulatory requirements.
15. Participate in research and educational activities related to clinical research and regulatory affairs as needed.
16. Represent the organization at external meetings and conferences related to regulatory compliance and clinical research.

According to JobzMall, the average salary range for a Clinical Research Regulatory Coordinator in Orlando, FL, USA is between $50,000 to $80,000 per year. This salary range can vary depending on factors such as experience, education, and specific job responsibilities. Some employers may offer additional benefits such as bonuses, health insurance, and retirement plans.

Orlando Health is a private, not-for-profit network of community and specialty hospitals based in Orlando, Florida. Orlando Health has award-winning hospitals, clinics and over 2000 physicians throughout Central Florida.