
Clinical Research Regulatory Coordinator
Welcome to Orlando Health, where we are committed to providing exceptional healthcare services to our community. As a Clinical Research Regulatory Coordinator, you will play a vital role in ensuring the ethical and regulatory compliance of our clinical research studies. We are seeking an organized and detail-oriented individual with a passion for improving patient outcomes through clinical research. 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.
Bachelor's Degree In A Relevant Field Such As Health Sciences, Nursing, Or Biology.
Minimum Of 2 Years Of Experience In Clinical Research, Preferably In A Regulatory Role.
Knowledge Of Regulatory Requirements And Guidelines For Conducting Clinical Trials, Including Fda Regulations And Good Clinical Practice (Gcp) Guidelines.
Excellent Organizational And Communication Skills, With The Ability To Manage Multiple Projects And Deadlines.
Familiarity With Electronic Data Capture Systems And Regulatory Document Management Tools.
Quality Assurance
Data collection
Project coordination
Regulatory compliance
Documentation management
SOP Development
Clinical Trials
Informed Consent
Protocol Management
Irb Submissions
Investigator Oversight
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Clinical Research Regulatory Coordinator in Ocoee, FL, USA is $51,000 to $74,000 per year. However, salaries may vary depending on the specific job responsibilities, experience, and qualifications of the individual.
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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.

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