Regulatory Affairs Specialist
hace 3 semanas
The University of Colorado Anschutz Medical Campus is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our Clinical Trials Unit, you will be responsible for providing regulatory support for clinical trials and investigator-initiated studies.
Key Responsibilities:
- Serve as the primary point of contact for regulatory matters related to clinical research studies.
- Ensure compliance with federal regulations and Good Clinical Practice (GCP) guidelines.
- Prepare and submit clinical research applications to regulatory bodies, including the Colorado Multiple Institutional Review Board (COMIRB) and the Hospital Research Support Services (UCH-RSS).
- Write and maintain accurate and up-to-date regulatory records, including informed consent documents and HIPAA Authorizations.
- Collaborate with the HCTU Leadership Team, Principal Investigators, and other departments on campus to ensure seamless study execution.
Why Work for Us?
The University of Colorado Anschutz Medical Campus is a world-renowned institution dedicated to advancing medical research and education. As a member of our team, you will have the opportunity to work with a talented group of professionals who are passionate about improving human health.
Qualifications:
- Bachelor's degree in any field.
- Minimum one year of clinical regulatory compliance or related experience.
- Excellent communication and organizational skills.
- Ability to work effectively in a fast-paced environment.
What We Offer:
- A competitive salary and benefits package.
- Opportunities for professional growth and development.
- A dynamic and supportive work environment.
How to Apply:
To be considered for this exciting opportunity, please submit your application, including a cover letter and resume, to the University of Colorado Anschutz Medical Campus Human Resources department.
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