Clinical Research Regulatory Coordinator

h. If you have a strong understanding of regulatory requirements, excellent communication skills, and a desire to make a difference in the field of healthcare, we encourage you to apply for this exciting opportunity.

Ensure compliance with all ethical and regulatory guidelines for conducting clinical research studies.
Maintain accurate and up-to-date knowledge of all applicable regulations and guidelines.
Develop and maintain relationships with regulatory agencies and institutional review boards.
Review and approve all study protocols, informed consent forms, and other study-related documents.
Collaborate with research teams to ensure proper implementation and execution of study protocols.
Monitor and track regulatory submissions, approvals, and expirations.
Conduct regular audits to ensure compliance with regulatory requirements.
Communicate any regulatory updates or changes to the research team.
Coordinate and facilitate site visits from regulatory agencies and sponsors.
Serve as the point of contact for all regulatory-related inquiries and requests.
Maintain accurate and organized records of all regulatory documentation.
Provide support and guidance to research team members on regulatory compliance.
Participate in the development and revision of standard operating procedures related to regulatory compliance.
Attend relevant training and continuing education to stay current on regulatory requirements.
Contribute to the development of new research initiatives and projects.
Serve as a liaison between the research team and regulatory agencies.
Work closely with the research team to ensure timely completion of all regulatory tasks.
Identify and report any potential compliance issues to the appropriate parties.
Maintain confidentiality of all sensitive and confidential information.
Promote a culture of ethical conduct and regulatory compliance within the organization.

Orlando Health is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.