Clinical Research Regulatory Specialist

At Children's Hospital Colorado, our Clinical Research Regulatory Specialists play a vital role in our research mission. By providing regulatory support and guidance, these professionals ensure that our clinical research studies are conducted in compliance with applicable regulations and standards. We are looking for a highly organized and detail-oriented individual with a commitment to excellence to join our team.The successful candidate will have a minimum of a Bachelor's degree in a relevant field such as healthcare administration, healthcare management, or science, as well as at least three years of experience in a clinical research setting. Knowledge of research regulatory standards, state, and federal regulations is essential, and experience in accreditation, quality improvement, and risk management is a plus. Additionally, this individual must have excellent organizational and communication skills, with the ability to work independently and collaboratively as part of a team.We are seeking an individual with a commitment to the highest standards of quality and integrity, with a passion for advancing our research initiatives. If this describes you, we invite you to apply for the position of Clinical Research Regulatory Specialist at Children's Hospital Colorado.

Responsibilities:

1. Maintain and ensure compliance with all applicable regulatory standards, state, and federal regulations related to clinical research.
2. Monitor research activities to ensure adherence to accreditation, quality improvement, and risk management standards.
3. Develop and implement process improvements for regulatory compliance.
4. Assist in the development and implementation of research policies and procedures.
5. Provide guidance and support to research teams on regulatory issues.
6. Manage and review research records and documents.
7. Ensure that research studies are conducted in accordance with ethical guidelines.
8. Monitor patient safety and compliance with regulations.
9. Prepare and submit reports to research sponsors and other regulatory agencies.
10. Maintain up-to-date records related to clinical research studies.

According to JobzMall, the average salary range for a Clinical Research Regulatory Specialist in Aurora, CO, USA is $62,000 - $89,000. This range is dependent on factors such as experience, qualifications, and the particular employer.

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.