Senior Research and Compliance Specialist

  • Oakland, CA
  • Legal and Compliance
  • Internal Audit & Compliance
  • Full Time - Day
  • Business Professional & IT
  • Req #: 27194-18079
  • Posted: July 27, 2020
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Summary

SUMMARY: Responsible for supporting the research and compliance functions by coordinating and participating in the development, oversight, and monitoring of the research compliance operations; performs complex, diversified administrative, operational functions for the Compliance Department; acts as liaison for the compliance team and fosters open lines of communication within AHS.

DUTIES & ESSENTIAL JOB FUNCTIONS:  NOTE: The following are the duties performed by employees in this classification.  However, employees may perform other related duties at an equivalent level.  Not all duties listed are necessarily performed by each individual in the classification.
 

1. Coordinates all aspects of the Institutional Review Board (IRB) process for compliance with governmental rules and regulations regarding research standards.

2. Monitors and provides assistance with the interpretation of emerging federal, state and local laws and regulations, as it relates to the review and oversight of research compliance.

3. Coordinates activities with Legal, Contracting and Grant Departments via IRB Manager Software for timely approval of IRB projects.

4. Coordinates IRB meeting management; committee support, agenda planning, and loop closure.

5. Coordinates preparation and planning for regulatory surveys; continuous survey readiness for Federal Drug Administration, Joint Commission, CMS, CDPH, EMTALA, and all regulatory compliance; develops strategies to identify gaps and recommendations to meet requirements.

6. Identifies concerns with the IRB process and facilitates solutions that promote and maintain positive professional relationships with medical staff and hospital administration.

7. Partners with Department leads in special projects, lending data expertise and actionable insights.

8. Performs routine and targeted audits and monitoring reviews to identify trends in potential compliance risks and recommends corrective action plans as necessary. 

9. Provides education and training to increase and strengthen AHS workforce awareness and understanding on a variety of compliance and privacy related topics.

10. Partners with management, project champions, and process owners to align process improvement initiatives with business objectives.

11. Provides assistance with updating the Compliance and Privacy intranet site with relevant materials.

12. Participates in the development, implementation and dissemination of ongoing compliance and privacy educational materials.

13. Provides support to redesign policies and procedures, operational processes and disseminate new material.

14. Performs data analysis of compliance reports for trends and potential issues.

15. Performs other duties as assigned.

Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying.

MINIMUM QUALIFICATIONS:

Required Education: Bachelor’s degree in related field.

Required Experience: Five years of healthcare compliance with in-depth knowledge of healthcare research rules regulations.

Preferred Licenses/Certifications: Research certification.

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