Director - Human Research Subjects Protection Program

JOB SUMMARY

The Director - Human Research Subjects Protection Program is responsible for the overall administration of the program for protecting human participants in research, including the oversight and implementation of, and compliance with, institutional policies and procedures, national statutes and regulations, and ethical and professional standards for the conduct of human research. The HRPP Director serves as the organization authority on relevant compliance issues and as a liaison between the organization and Ministry of Public Health.

Responsibilities KEY ROLE ACCOUNTABILITIES

• Maintains the institution assurance of compliance with the Ministry of Public Health (MOPH) and the U.S. Office for Human Research Protections (OHRP) and ensures adherence to their terms for the protection of human subjects.
• Works collaboratively with the Chairs of regulatory committees, Department Chairs, institution administration to provide support, compliance monitoring and oversight, and facilitate ethical conduct of research.
• Oversees and coordinates HRPP activities across the various offices and staff that have roles in protecting research participants.
• Coordinates with Sidra's Divisions and Units for implementing other aspects of human research protection programs and initiatives.
• Proactively creates or revises policies and procedures and corresponds guidance to assure consistency with best practices and evolving external policies from MOPH.
• Manages and supervises the staff that provides administrative and regulatory support to the IRB Committee.
• Develops, modifies and executes policies that affect immediate operation(s) and may also have organization-wide effect.
• Coordinates efforts of the IRB Office staff to ensure thorough and timely reviews of all IRB submissions.
• Administers the Responsible Conduct of Research training coordination.
• Provides subject matter-specific counsel to HRPP team members, Board members, and investigators.
• Ensures that human research protection training is available and completed by investigators, key study personnel, the Institutional Signatory Official, and all Sidra staff who participate in the human subject's protection program.
• Oversees the quality assurance monitoring of the HRPP, including research protocols and investigation of matters of non-compliance. Ensure implementation of corrective action, as needed, in accordance with Sidra policies and IRB policies and procedures.
• Serves as the organization authority on relevant compliance issues, and as a liaison between the organization and federal regulators,
• Oversees and is accountable for policies and procedures related to relevant compliance area.
• Reviews and approves recommendations for research compliance programs.
• Maintains current knowledge of human research protection guidance and regulations as they evolve. Stay current on emerging issues. Monitors MOPH regulatory websites and other research-related resources so as to stay current with regulatory changes in human research protections guidelines and policies. Communicate pertinent information to staff in a timely manner.
• Establishes objectives and work plans, and delegate's assignments to subordinate managers.
• Coordinates and participates in regulatory agency site visits and audits; analyzes and assesses audit findings and proposes and implements changes to HRPP policies and procedures to address findings, when needed.
• Manages, prepares, administers, and directs resources

QUALIFICATIONS & EXPERIENCE Education

Bachelor's Degree in biomedical field

Experience

10+ years of experience with progressive responsibilities in the human subject protection program area or in other research protection programs, clinical research, or management of human research including:

• 5+ years direct supervisory / management experience.
• Previous leadership experience combined with a proven and demonstrated track record of leading others and achieving outstanding results.
• Expertise and experience in supervision and oversight of IRBs at an Academic Medical Center
• Experience in budget management.

Certification

Council for Certification of IRB Professionals (CCIP) certification or willingness to obtain within six months.