
Clinical Research Regulatory Specialist
At Children's Hospital Colorado, we are seeking a talented and highly motivated Clinical Research Regulatory Specialist to join our team. The ideal candidate will be detail-oriented and organized, and have a passion for ensuring that our clinical research is conducted with the utmost compliance and accuracy. The Clinical Research Regulatory Specialist will be responsible for providing regulatory guidance and expertise to the research team and will be a key contributor in ensuring that our research activities are conducted to the highest standards.The successful candidate will have a Bachelor's degree in a relevant field and a minimum of three years of experience in a clinical research regulatory environment. Additionally, they should have excellent organizational skills and the ability to work independently and collaboratively in a fast-paced environment. They should also be comfortable working with a variety of research teams and have the ability to effectively communicate with team members at all levels. Finally, they must possess a high level of integrity and a commitment to protecting patient safety.If you are seeking an opportunity to make a difference in the lives of our patients through your clinical research regulatory expertise, we invite you to apply today!
Responsibilities:
- Provide regulatory guidance and expertise to the research team.
- Ensure research activities are conducted to the highest standards of compliance and accuracy.
- Develop and maintain strong relationships with research teams of all levels.
- Monitor and track all regulatory compliance related activities.
- Liaise with external regulatory agencies as necessary.
- Manage the review and approval of all research-related documents.
- Develop and implement research protocols and procedures.
- Develop educational materials related to regulatory requirements and best practices.
- Ensure all research activities adhere to applicable laws and regulations.
- Monitor and evaluate research data for accuracy and compliance.
- Conduct periodic audits of research activities to ensure compliance with regulations.
- Ensure research activities are conducted with the utmost safety and privacy of patients.
- Prepare and submit reports as required by regulatory bodies.
Excellent Organizational And Communication Skills
Ability To Interpret
Bachelor’s Degree In A Healthcare-Related Field Or Equivalent Experience
Knowledge And Experience Of Applicable Regulations
Laws And Guidelines
Explain And Apply Complex Regulations And Guidelines
Ability To Work Independently And With A Team
Ability To Plan And Prioritize Work In A Rapidly Changing Environment
Working Knowledge Of Clinical Research Protocols And Technical Documents
Recent Experience In The Healthcare Industry
Data Analysis
Writing
Clinical Research
FDA
Auditing
MS Office
Compliance
GCP
Monitoring
Negotiations
Regulatory
Clinical Trials
Ethics
Protocols
Ich
Communication
Leadership
Negotiation
Problem Solving
Time management
Interpersonal Skills
creativity
Organizational skills
Teamwork
Adaptability
According to JobzMall, the average salary range for a Clinical Research Regulatory Specialist in Aurora, CO, USA is $64,000 to $93,000 per year. This salary range is based on salaries reported by various employers in the area, as well as the relevant job market data.
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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.

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