Associate Director of Human Research Protections

ASSOCIATE DIRECTOR-HUMAN RESEARCH PROTECTIONS

Scope:
Provides leadership for and operationalizes client's Human Research Participant Protection Program (HRPPP); ensures regulatory compliance, human subjects protection, and quality improvement for the HRPPP; provides guidance and implements best practices as they relate to HRPPP staff throughout the organization, the nine internal Institutional Review Boards (IRBs), and investigators and research staff; develops and administers policies and procedures for the protection of human subjects in research, and assures institutional compliance with applicable federal and state regulations.

Job Summary:
§ Provides leadership for and operationalizes Human Research Participant Protection Program (HRPPP); 20% of time
§ Ensures regulatory compliance, human subjects protection, and quality improvement for the HRPPP; 15% of time
§ Provides guidance and implements best practices as they relate to HRPPP staff throughout the organization, the nine internal Institutional Review Boards (IRBs), and investigators and research staff; 15% of time
§ Develops and administers policies and procedures for the protection of human subjects in research, and assures institutional compliance with applicable federal and state regulations; 15% of time
§ Consults with leadership (including the Federal wide Assurance (FWA) Institutional Official) with respect to institutional research compliance development, implementation and management; 10% of time
§ In coordination with the eight client regions and eight Medical Groups, leads the IRB function to ensure compliance with federal, state, and local regulations and client's policies and procedures; 10% of time
§ Assists in the planning, implementation, delivery, integration and evaluation of strategic research initiatives; 10% of time
§ Performs other duties as assigned. 5% of time 

IRB Institutional Review Board

Essential Duties:
1. Provides consultation with institutional leaders, FWA Institutional Official, IRB Chairs and Administrators, researchers, and other research stakeholders on complex research issues. Resolves questions or conflicts and provides clarifications regarding regulatory or policy matters related to the HRPPP. Collaborates with multiple stakeholders and IRBs to maximize efficiency while improving human subject protection to facilitate multiregional research. 20% of time
2. Supervises staff and oversees systems to track and report IRB Authorization Agreements, Independent Investigator Agreements, regulatory agency communications, GINA (Genetic Information Nondiscrimination Act) Notices of Research Exception; as well as systems to revise and renew the FWA and IORG. 15% of time
3. Assists HRPPP Director to develop annual IRB Leadership meeting program and develops agenda, leads, and documents monthly IRB Administration conference calls. 15% of time
4. Monitors and analyzes new legislation, federal regulations, guidance documents, and program initiatives to keep abreast of current trends and changes in the research community and implement effective strategies to ensure HRPPP compliance; including drafting, updating, and monitoring HRPPP Standard Operating Procedures. Updates appropriate contacts on latest regulatory and policy developments. 10% of time
5. Establishes and implements strategies for quality assurance activities, including HRPPP review activities and other quality assurance and quality improvement (QA/QI) activities. Monitors HRPPP and other data sources to assure internal quality, consistency of information, and adherence to regulatory timelines and requirements. Coordinates quality assurance and improvements with other groups as required. 10% of time
6. Advises the FWA Institutional Official of unanticipated problems involving risks to human subjects or others and alleged and documented serious and/or continuing non-compliance. Supports activities of the regional IRB Directors, Administrators, and Chairs and works to ensure consistent practices across the organization.10% of time
7. Collaborates with the Education and Training on the delivery of HRPPP training. 5% of time 8. Advises FWA Institutional Assurance Official on Certificate of Confidentiality applications, IRB Authorization Agreements, Independent Investigator Agreements. 5% of time
9. Develops and maintains important strategic relationships with federal regulators. Represents the HRPPP at internal and external meetings as required. 5% of time
10. Develops and maintains contacts with peers at other institutions, monitors on-going national discussions on regulatory and ethics issues. 5% of time

Requirements:

Required:

§ Master's or Doctoral Degree, or Bachelor's Degree with clinical qualifications (eg, RN, NP)
§ 8-10 years work experience
§ Minimum of five years of IRB management experience
§ Working knowledge of regulations related to human subjects research (eg, Common Rule, FDA IND/IDE regulations, ICH GCP, HIPAA, GINA)
§ Certified IRB Professional (CIP) designation required within one year of appointment to the position
§ Supervisory experience (3-5 years)
§ Proficiency with computer work, including Microsoft Office
§ Experience in clinical research preferred: 7+ years
§ Work in large organizations
§ Consensus-driven management style
§ OUTSIDE THE BOX THINKING, BUT ABLE TO MAINTAIN REGULATORY COMPLIANCE