Clinical Research Reg Coord

Are you passionate about improving patient outcomes through clinical research? Do you have experience in coordinating and managing research studies? Orlando Health is seeking a highly motivated and detail-oriented Clinical Research Regulatory Coordinator to join our dynamic team. In this role, you will play a crucial part in ensuring compliance with regulatory requirements and ethical standards, as well as facilitating the successful execution of various research studies. If you have a strong background in clinical research and are looking for a challenging and rewarding opportunity, we would love to hear from you!

1. Coordinate and manage multiple research studies, ensuring all activities are conducted in accordance with relevant protocols, regulations, and ethical standards.
2. Serve as the primary point of contact for investigators, study sponsors, and regulatory agencies, providing timely and accurate updates on the progress of research studies.
3. Develop and maintain study documents, including protocols, informed consent forms, and regulatory submissions, ensuring they are complete, accurate, and up-to-date.
4. Prepare and submit regulatory documents to institutional review boards (IRBs) and other regulatory bodies, ensuring compliance with all applicable regulations and guidelines.
5. Maintain and update study databases and records, ensuring data integrity and accuracy.
6. Coordinate study start-up activities, including site initiation visits, investigator meetings, and training for study team members.
7. Collaborate with study team members to ensure timely completion of study milestones and deliverables.
8. Monitor and track study progress, identifying and addressing any issues or concerns that may arise.
9. Participate in study audits and inspections, addressing any findings and ensuring timely resolution of any identified issues.
10. Stay current with relevant regulations, guidelines, and best practices related to clinical research, and apply this knowledge to study activities.
11. Communicate effectively with all stakeholders, including investigators, study team members, sponsors, and regulatory agencies.
12. Adhere to all applicable laws, regulations, and institutional policies and procedures related to human subjects research.
13. Maintain confidentiality and protect the rights and welfare of study participants at all times.
14. Contribute to the development and implementation of standard operating procedures and processes related to clinical research.
15. Participate in the training and mentoring of new team members, as needed.

According to JobzMall, the average salary range for a Clinical Research Reg Coord in Orlando, FL, USA is $55,000 to $80,000 per year. This range can vary depending on factors such as experience, education, and the specific organization or industry the coordinator works for.

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.