Clinical Research Regulatory Specialist

Are you passionate about ensuring the safety and ethical conduct of clinical research studies? Do you have a strong understanding of regulatory requirements in the healthcare industry? If so, we have the perfect opportunity for you at Children's Hospital Colorado! As a Clinical Research Regulatory Specialist, you will play a crucial role in ensuring compliance with all regulatory standards and guidelines for our cutting-edge pediatric research studies. We are seeking a detail-oriented and knowledgeable individual to join our dynamic team and make a meaningful impact on the lives of children and families. If you have the required qualifications and a passion for advancing pediatric healthcare through research, we encourage you to apply for this exciting position.

1. Ensure compliance with all regulatory standards and guidelines for clinical research studies at Children's Hospital Colorado.
2. Develop and maintain a thorough understanding of healthcare industry regulations, including Good Clinical Practice (GCP) guidelines and federal and state laws.
3. Act as the primary point of contact for regulatory agencies and provide timely and accurate responses to inquiries and audits.
4. Collaborate with research teams to ensure that all necessary regulatory documents and protocols are in place and up to date.
5. Monitor and track regulatory submissions and approvals, and maintain accurate and organized records.
6. Review informed consent forms and study protocols for compliance with regulatory requirements.
7. Provide guidance and support to research staff on regulatory issues and assist with resolving any compliance-related issues.
8. Conduct internal audits to ensure ongoing compliance and identify areas for improvement.
9. Participate in the development and implementation of training programs and educational materials related to regulatory compliance.
10. Stay up to date on changes in regulations and communicate any updates or changes to the research team.
11. Maintain confidentiality of sensitive information and ensure the security of all regulatory documents.
12. Serve as a subject matter expert and resource for all regulatory-related inquiries.
13. Monitor and report on any potential risks or non-compliance issues and work with the appropriate parties to address and resolve them.
14. Maintain a positive and collaborative working relationship with all members of the research team.
15. Continuously seek opportunities to improve and streamline regulatory processes and procedures.

According to JobzMall, the average salary range for a Clinical Research Regulatory Specialist in Denver, CO, USA is between $70,000 and $100,000 per year. This can vary depending on factors such as the specific company, years of experience, and education level. Some employers may also offer additional benefits and bonuses. It is important to research the specific job and company to get a more accurate salary estimate.

Children's Hospital Colorado is a academic pediatric acute care children's hospital located in the Anschutz Medical Campus near the interchange of I-225 and Colfax Avenue in Aurora, Colorado. The hospital has 434 pediatric beds at its main campus in Aurora.