The Research Compliance Director is accountable for overseeing the region's research compliance with local, state and federal regulations, regional and Program Office policy. This position directs all research compliance activities in the NW Region. This includes chairing the research compliance committee, managing human subjects protection, ensuring all research is in compliance with applicable laws, regulations, policies, and procedures. This position acts as the Research Conflict of Interest Officer, including oversight of the federal requirements and corresponding KP policy for FCOI. This position is accountable for the development, administration and direction of Institutional Review Board (IRB) policies and procedures for KPNW. This position provides direction for clinical trials compliance and HIPAA compliance. This position is responsible for collaborating at the national KP level for research compliance and human subject's protection and for providing research compliance guidance to CHR Hawaii and CHR Georgia. This position reports to the Regional Compliance Officer and has functional 'dotted line' accountability to the Executive Director and Chief Operating Officer for Research.
Essential Functions:
- Direct overall research compliance activities for the Northwest Region. This includes chairing the regional research compliance committee and the TCHR research compliance committee (with membership from KP Northwest, KP Hawaii and KP Georgia).
- Direct and provide oversight for human subject's protection for KPNW research, meeting all regulatory requirements as well as CHR standards and policies.
- Direct the administration of the KPNW IRB, including supervision of RSPO staff, planning, developing, implementing, and managing IRB policies and procedures for KPNW. This includes management of the IRB computerized information system.
- Act as the Research Conflict of Interest Officer, including oversight over policies related to research conflict of Interest (COI) and direct remediation of COI issues.
- Act as a Liaison to national staff related to COI.
- Represent KPNW in the area of Research Compliance within KP nationally, including COI, clinical trials compliance, and human subject's protection.
- Direct the area of clinical trials compliance, including oversight over ongoing clinical trials monitoring and reporting. This includes management of clinical trials compliance staff, and coordination of clinical trials compliance initiatives across the three regions of TCHR.
- Direct activities of research compliance related to data sharing and data use. This includes supervision of staff involved in supporting data use and data transfer agreements.
- Act as member of CHR Leadership team to integrate research compliance within overall strategic initiatives of CHR.
- Other duties as requested.
Qualifications:
Basic Qualifications:
- Seven (7) years in a research administrative or management position in a health or human services organization which included working with both professional and lay people.
- Five (5) years of experience in research compliance.
- Five (5) years of supervisory experience and coordination skills to oversee work of others.
- Experience working with a decision-making Board.
- Master's degree in a relevant social science, business, management, or health-related field.
- Working knowledge of medical or health-related research, medical terminology.
- Familiarity with federal regulations relating to research.
- Working knowledge of research ethics and the research process.
- Demonstrated aptitude for self-motivation, collaboration.
- Proven management skills for multiple priorities and activities with demonstrated attention to details.
- Excellent interpersonal skills, accomplished oral and written skills.
- Demonstrated ability to write concisely and effectively.
Preferred Qualifications:
- Ten (10) years in a research administrative or management position in a health or human services organization which included working with both professional and lay people preferred.
- Seven (7) years of experience with research compliance preferred.
- Seven (7) years of supervisory experience and coordination skills to oversee work of others preferred.
- Experience working with leadership level staff preferred.
- Thorough knowledge, skill, and experience with: Research Compliance, Research Conflict of Interest, HIPAA regulations for privacy and security, FDA Regulations, OPRR Regulations, Institutional Review Boards, Research ethics and confidentiality policies, and good clinical practice guidelines for clinical trials preferred.
- Working knowledge, skill, and experience with: KP and research design preferred.
- Doctoral degree (e.g., PhD, MD, ScD, DrPH, DNSc, DDS) in a scientific field related to health or health services research (e.g., social/behavioral science, epidemiology, biostatistics, medicine, dentistry, nursing) preferred.
- Demonstrated aptitude for self-motivation, collaboration preferred.
- Proven management skills for multiple priorities and activities with demonstrated attention to details preferred.
- Demonstrated negotiation, persuasion, verbal communication skills preferred.
- Demonstrated ability to write concisely and effectively preferred.
- Ability to adopt and maintain computerized tracking information system preferred.
External hires must pass a background check/drug screen.
We are proud to be an equal opportunity/affirmative action employer.