Where Ambition and
Innovation Meet with Care

Job Details

SIDRA4648 - Director – Institutional Review Board (IRB)

Department: Research Administration Div
Division: Research Services Dept
Contract Type: Full Time
Closing Date: 28-Feb-2019
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

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.

Person:

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.

Experience:
  • 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.

  • Provides leadership, guidance, and management to all aspects of the day-to-day IRB operations;

  • 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 

 PREFERRED

           Education
  •  Bachelor’s Degree in biomedical field
  • Advanced Degree in biomedical field
           Experience

  • 10+ years of experience with progressive responsibilities in relevant field including:
  • 5+ years’ experience with human research protections activities

  • Proven success in managing an IRB

  • Experience in budget management.

 

 

  •  Experience managing an IRB and mentoring staff during a period of significant change.

Certification and Licensure 

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

Job Specific Skills and Abilities 

  • Detailed knowledge of the Common Rule and ICH GCP and IRB processes that meet these requirements.                

 

Sidra’s Organizational Values:
  • Trust: Being competent; acting consistently, reliably and predictably; acting with honesty and integrity; respecting patient, employee and commercial confidentiality; delivering on commitments
  • Care: Acting with empathy, kindness and compassion; being humble; listening and responding; acting with cultural sensitivity; Caring for patients and staff
  • Teamwork: Sharing information and knowledge and learning from demonstrated expertise; being respectful, and thereby earning respect of others; acting with professionalism; leading and following; collaborating and being accessible
  • Transparency: Frequent and honest communication; open access to information for decision making; willingly acknowledge shortcomings; speaking up about concerns; publishing performance indicators
  • Innovation: Freedom to innovate; welcoming ideas and encouraging creativity; supporting talent; creating confidence; celebrating successes
  • Efficiency: Providing measurable value; using data to drive decision making; having and achieving clear goals; building processes that work; continuously improving outcomes in patient and family care
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