Organizational Profile :
Sidra Medicine is a state of the art academic medical center that will function to the level of the highest international standards.
Its clinical focus is on the specialty care of women and children.
Sidra’s Vision is : Sidra Medicine will be a beacon of learning, discovery and exceptional care, ranked among the top medical centers in the world .
Achieving this vision will encompass three essential activities :
World Class : Patient and Family Centered Care Health Education Biomedical Discovery
Once fully operational by mid-2018, Sidra Medicine will handle 275,000 outpatient appointments, 11,000 procedures, 100,000 emergency attendances and deliver over 9,000 babies per year, adding capacity to a rapidly growing population and delivering world-class specialist care.
The hospital will include 10 operating theatres, 400 beds, 100 percent single rooms with a private bathroom, a birthing center and an emergency department.
The Research branch will house several hundred researchers working on many aspects of Feto-maternal health. It will cover Basic, Translation, Clinical trials and Informatics research.
The department comprises two research floors totaling 10,000M2 and 9 smaller satellite laboratories throughout the hospital.
The department will house basic laboratories as well as state-of-the-art core facilities, e.g. Genomics, Medicinal Chemistry and Imaging
This role reports to Office of the General Counsel.
The Director Institutional Review Board (IRB) is responsible for transforming the IRB to meet the demands of a world-class research institution and for sustaining this level of excellence, once achieved.
Excellence will include efficient operations, a high level of service to investigators, and oversight of human subjects research in compliance with regulatory and ethical standards as well as institutional policies and procedures.
Leads a significant institutional effort to review and streamline institutional policies and IRB processes to meet the needs of a JCI-
accredited, world-class academic medical center.
Leads the procurement, customization, and implementation of a new IRB software platform.
Ensures a high level of service to investigators interacting with the IRB.
Oversees the process of screening and pre-reviewing IRB applications, manage communications and official IRB determinations to investigators.
Plans and facilitates regular and special meetings of the IRB. Oversees preparation of the IRB meetings, minutes & IRB decisions.
Oversees and ensures proper operation of the IRB review process.
Develops and analyzes key operational and performance metrics.
Functions as a designated reviewer for exempt research application.
Hires, trains, supervisse, and evaluates personnel within the IRB office. Monitors staff workloads and redistribute as needed.
Attends IRB meetings to advise on applicable regulations, institutional policies and ethical principles. Ensures the committee meets regulatory requirements.
Provides guidance on interpretation of Qatari and international regulations to researchers, staff and administrators.
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.
Maintains IRB study-related documentations in accordance with MOPH regulations, institutional policies and funding agency requirements.
Conducts orientation and training to IRB members on topics related to their responsibilities, regulations, policies and procedures.
Serves as liaison between the institution & the regulatory agencies. Communicates as needed with regulatory agencies on matters relating to human subject protections.
Prepares and oversees the IRB budget.
Guides and facilitates IRB management system updates, including business requirements and user acceptance testing.
Evaluates and provides advice when an Institutional Authorization Agreements (IAA) is to be signed.
Coordinates and participates in regulatory agency site visits and audits; analyzes and assesses audit findings and proposes and implements changes to IRB policies and procedures to address findings, when needed.
Evaluates reported issues of unanticipated problems, adverse events, and complaints. Identifies, manages, and resolves instances of non-
compliance. Advises and informs the IRB committee review of these issues in accordance with Local and international regulations.
Reports non-compliance issues, unanticipated problems involving risks to subjects, suspension and termination to the Institutional Official and / or his delegate.
Provides guidance and input on reports to regulatory agencies and to sponsors, regarding noncompliance, suspension or termination of research, or unanticipated problems involving subjects or others.
Drafts these reports if required.
Adheres to Sidra’s standards as they appear in the Code of Conduct and Conflict of Interest policies.
Adheres to and promotes Sidra’s Values.
Qualifications : ESSENTIAL
5+ years’ experience with human research protections activities
Proven success in managing an IRB
Experience in budget management.
Certification and Licensure
Job Specific Skills and Abilities
Detailed knowledge of the Common Rule and ICH GCP and IRB processes that meet these requirements.