Legacy Health

Research Regulatory Specialist

Legacy Health

Portland, OR, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Are you passionate about ensuring ethical and compliant research practices? Do you have a strong understanding of regulatory guidelines and procedures? If so, we have an exciting opportunity for you to join our team as a Research Regulatory Specialist at Legacy Health.In this role, you will play a crucial role in promoting the ethical and responsible conduct of research within our organization. You will utilize your expertise in regulatory requirements to guide and support our researchers, ensuring that all studies are conducted in accordance with applicable laws, regulations, and policies.To excel in this position, you must possess a keen attention to detail, exceptional organizational skills, and the ability to effectively communicate complex information to a diverse audience. A minimum of 2 years of experience in a research regulatory role and a Bachelor's degree in a related field are also required.If you are seeking a challenging and rewarding opportunity to make a difference in the field of research, we invite you to apply for this role at Legacy Health. Join our team and help us advance healthcare through responsible and ethical research practices.

  1. Develop and maintain a thorough understanding of all relevant laws, regulations, and policies related to research compliance.
  2. Provide guidance and support to researchers to ensure their studies are conducted in accordance with applicable regulations and policies.
  3. Review research protocols and documents to ensure compliance with regulatory requirements.
  4. Develop and implement training programs to educate researchers on ethical and compliant research practices.
  5. Monitor and track all ongoing research projects to ensure continued compliance with regulatory guidelines.
  6. Facilitate the submission and approval process for research protocols and necessary regulatory documents.
  7. Conduct internal audits to identify any potential compliance issues and develop corrective action plans.
  8. Collaborate with external agencies and organizations to stay updated on changes to regulatory requirements.
  9. Communicate complex regulatory information and updates to a diverse audience, including researchers, staff, and external partners.
  10. Maintain accurate and up-to-date records of all research compliance activities.
  11. Participate in the development and review of policies and procedures related to research compliance.
  12. Serve as a resource for all research-related compliance inquiries and issues.
  13. Stay informed of industry best practices and make recommendations for process improvements.
  14. Uphold a high standard of ethical conduct and promote a culture of research integrity within the organization.
  15. Collaborate with other departments, such as legal and human resources, to ensure research compliance across all areas of the organization.
Where is this job?
This job is located at Portland, OR, USA
Job Qualifications
  • Bachelor's Degree In A Relevant Field Such As Health Sciences, Public Health, Or Healthcare Administration.

  • At Least 2 Years Of Experience In Research Compliance And Regulatory Affairs, Preferably In A Healthcare Setting.

  • Knowledge And Understanding Of Federal And State Regulations Related To Human Subject Research, Such As Hipaa And Fda Regulations.

  • Excellent Communication And Interpersonal Skills, With The Ability To Work Collaboratively With Diverse Stakeholders.

  • Strong Attention To Detail And Organizational Skills, With The Ability To Manage Multiple Projects Simultaneously And Meet Deadlines.

Required Skills
  • Quality Assurance

  • Clinical Research

  • Risk assessment

  • Regulatory compliance

  • Documentation management

  • Regulatory reporting

  • Data Auditing

  • Protocol Review

  • Informed Consent

  • Investigator Training

  • Ethics Committee

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Critical thinking

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Research Regulatory Specialist in Portland, OR, USA is between $60,000 and $80,000 per year. This range can vary depending on factors such as level of experience, specific job responsibilities, and the employer. Some companies may offer additional benefits and bonuses, which can also impact the overall salary range.

Additional Information
Legacy Health 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 PostedFebruary 7th, 2024
Apply BeforeMay 22nd, 2025
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About Legacy Health

Legacy Health is a non-profit hospital system located in Portland, Oregon, United States. It consists of six primary-care hospitals, a children's hospital, and allied clinics and outpatient facilities. The system employs about 14,000 staff members, and is the second-largest system in the Portland metro area, after the Providence Health System.

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