Children's Hospital Colorado

Clinical Research Regulatory Specialist

Children's Hospital Colorado

Aurora, CO, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

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:

  1. Provide regulatory guidance and expertise to the research team.
  2. Ensure research activities are conducted to the highest standards of compliance and accuracy.
  3. Develop and maintain strong relationships with research teams of all levels.
  4. Monitor and track all regulatory compliance related activities.
  5. Liaise with external regulatory agencies as necessary.
  6. Manage the review and approval of all research-related documents.
  7. Develop and implement research protocols and procedures.
  8. Develop educational materials related to regulatory requirements and best practices.
  9. Ensure all research activities adhere to applicable laws and regulations.
  10. Monitor and evaluate research data for accuracy and compliance.
  11. Conduct periodic audits of research activities to ensure compliance with regulations.
  12. Ensure research activities are conducted with the utmost safety and privacy of patients.
  13. Prepare and submit reports as required by regulatory bodies.
Where is this job?
This job is located at Aurora, CO, USA
Job Qualifications
  • 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

Required Skills
  • Data Analysis

  • Writing

  • Clinical Research

  • FDA

  • Auditing

  • MS Office

  • Compliance

  • GCP

  • Monitoring

  • Negotiations

  • Regulatory

  • Clinical Trials

  • Ethics

  • Protocols

  • Ich

Soft Skills
  • Communication

  • Leadership

  • Negotiation

  • Problem Solving

  • Time management

  • Interpersonal Skills

  • creativity

  • Organizational skills

  • Teamwork

  • Adaptability

Compensation

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.

Additional Information
Children's Hospital Colorado is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedOctober 25th, 2023
Apply BeforeMay 22nd, 2025
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About Children's Hospital Colorado

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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