Institutional Review Board (IRB) Specialist

The IRB Specialist of the Institutional Review Board (IRB) reports to the Team Lead – Institutional Review Board (IRB). The incumbent along with a team of other professionals is responsible for conducting pre-reviews of submissions to Sidra IRB, including new protocols, continuing reviews, modifications, and unanticipated problems. S/he regularly or on a periodic basis attends IRB meetings and also provides support to his/ her Manager, IRB Chair, and IRB Members, including writing and editing minutes of meetings. Additionally, the IRB Specialist has responsibilities related to the generation, review, and release of IRB correspondence. The IRB Specialist conducts quality control functions for the IRB office that may extend to all areas of the operation including review of files and meeting minutes for completeness, accuracy and consistency.

Further, this staff member helps to ensure uniformity of review and compliance with IRB standard operating procedures and applicable International regulations and Qatar Ministry of Public Health regulations. In addition, this candidate maintains up to date knowledge of regulations as well as policies, guidelines and ethical codes related to the protection of human subjects in research. This individual coordinates the implementation and management of the Institutional Review Board (IRB) related efforts; acts independently in carrying out tasks relevant to IRB compliance.

KEY ROLE ACCOUNTABILITIES:

• Reviews and updates IRB Policies and Procedures, creates department standard operating procedures with the other department stakeholders (IRB Lead and HRPP Director)

• Reviews and processes IRB protocol applications submitted by other research staff, acts as a resource for any and all IRB related matters.

• Ensures accuracy of IRB applications.

• Responsible for the review of IRB submissions for completeness prior to agenda assignment.

• Generates and analyzes reports of the IRB database for quality assurance purposes and assists with protocol audits.

• Communicates and interfaces with external Institutions on regulatory compliance for IRB submissions.

• Act as the liaison between the IRB Board and research staff with regard to study related information.

• Interprets and provides guidance to researchers on IRB operating practices and procedures.

• Ensures researchers have all information they need regarding the new submission of their study including handling inquiries and providing timely follow up.

• Prepares and distributes IRB meeting agenda and minutes.

• Attends IRB meetings and takes notes on agenda items and discussions.

• Maintains confidential office research files.

• Verifies and maintains record of certification of the Collaborative Institutional Training Initiative (CITI) course in the protection of human research subjects for key study personnel involved in human subjects research at Sidra and affiliated institutions.

• Monitors accounts receivable/ payable for IRB review fees and creates monthly invoice reports

• Performs routine personnel functions such as paper filing and file retrieval, responding to IRB emails, distributing mail, and receiving incoming calls.

• Support the department in Admin requests (e.g. raise department related requisitions and follow up until completion of payment settle).

• Oversees meeting availability of IRB members for monthly meetings; Oversees catering for monthly IRB meetings and for IRB Insights training.

• 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

In view of the evolving needs and opportunities within Sidra, this position may be required to perform other duties as assigned and reporting relationships may vary.

QUALIFICATIONS, EXPERIENCE AND SKILLS – ESSENTIAL REQUIREMENTS:

Education: Bachelor’s degree in the biomedical field

Experience: 5+ years’ relevant experience

Certification and Licensure: Collaborative Institutional Training Initiative (CITI) course in the protection of human research subjects

Job Specific Skills and Abilities:

• Proactive; strong organizational skills;

• Demonstrated knowledge of organizational and administrative support processes.

• Demonstrated proficiency taking and transcribing notes and minutes and/ or formal proceedings.

• Excellent verbal and written communication and interpersonal skills.

• Ability to take directions and work independently; the ability to prioritize, problem solve and work under pressure

• Proficiency with Microsoft Office suite

• Fluency in written and spoken English