Director - Human Research Subjects Protection Program

Role Overview

Director - Human Research Subjects Protection Program at Sidra Medicine. This role provides overall administration of the program for protecting human participants in research, including oversight and implementation of institutional policies and procedures, national statutes and regulations, and ethical and professional standards for the conduct of human research.

Company Overview

Sidra Medicine is a high-tech facility providing world-class patient care, scientific expertise, and educational resources. The organization delivers comprehensive specialist healthcare services for children and young people, and exceptional maternity, gynecology, and reproductive medical services for women.

Role Purpose

The HRPP Director serves as the organization authority on relevant compliance issues and as a liaison between the organization and the Ministry of Public Health. The role ensures institutional assurance of compliance with Ministry of Public Health and U.S. Office for Human Research Protections standards while facilitating the ethical conduct of human research across the organization.

Key Responsibilities

Compliance & Regulatory Oversight

• Maintain institutional assurance of compliance with the Ministry of Public Health and U.S. Office for Human Research Protections.
• Ensure adherence to Ministry of Public Health and U.S. Office for Human Research Protections terms for the protection of human subjects.
• Serve as the organization authority on relevant compliance issues.
• Oversee and assess audit findings and propose and implement changes to HRPP policies and procedures to address findings when needed.
• Coordinate and participate in regulatory agency site visits and audits.

Policy & Procedure Development

• Proactively create or revise policies and procedures to assure consistency with best practices and evolving external policies from Ministry of Public Health.
• Develop, modify, and execute policies that affect immediate operations and may have organization-wide effect.
• Oversee and be accountable for policies and procedures related to relevant compliance areas.
• Review and approve recommendations for research compliance programs.

Program Administration & Coordination

• Oversee and coordinate HRPP activities across various offices and staff that have roles in protecting research participants.
• Coordinate with Sidra's Divisions and Units for implementing other aspects of human research protection programs and initiatives.
• Coordinate efforts of the IRB Office staff to ensure thorough and timely reviews of all IRB submissions.
• Administer Responsible Conduct of Research training coordination.
• Manage and supervise staff that provides administrative and regulatory support to the IRB Committee.

Quality Assurance & Monitoring

• Oversee 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.

Stakeholder Support & Guidance

• Work collaboratively with Chairs of regulatory committees, Department Chairs, and institution administration to provide support, compliance monitoring, and oversight.
• Provide subject matter-specific counsel to HRPP team members, Board members, and investigators.
• Facilitate ethical conduct of research across the organization.

Training & Education

• Ensure 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 subjects protection program.

Regulatory Knowledge & Communication

• Maintain current knowledge of human research protection guidance and regulations as they evolve and stay current on emerging issues.
• Monitor Ministry of Public Health regulatory websites and other research-related resources to stay current with regulatory changes in human research protections guidelines and policies.
• Communicate pertinent information to staff in a timely manner.
• Serve as liaison between the organization and federal regulators.

Staff Management & Planning

• Establish objectives and work plans and delegate assignments to subordinate managers.
• Manage, prepare, administer, and direct resources.

Qualifications & Experience

• Bachelor's Degree in biomedical field.
• 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.
• 5+ years direct supervisory or 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.
• Council for Certification of IRB Professionals certification or willingness to obtain within six months.