Research Administration under the Support Services

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Description

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icddr,b is a Bangladesh-based international health research institute that strives to solve key public health problems through high-quality scientific research and innovation. As a values-based organization, icddr, b encourages women and people with disabilities to apply for opportunities. 

The Research Administration Department under Support Services Division is mandated to provide centrally managed research administration services to the scientific divisions and administer icddr,b’s research activities, and other businesses to enable them to attain their goals. 

Responsibilities:

The position IRB Coordinator, reporting to the Senior Manager of Research Administration, will primarily organize and monitor the processes and activities of the Institutional Review Board (IRB) hosted by the Research Administration Department at icddr,b. This position will ensure adherence to the quality, integrity, and standards of research conducted at icddr,b within the global guidelines for IRB and icddr,b’s Institutional Governance Framework. 

IRB Coordinator will be responsible for the following:

• Institutional Review Board (IRB) Process Development: Development, implementation, and update IRB policies and procedures to align with the regulations and ethical standards. Ensure the research involving human subject is conducted ethically, legally, and in compliance with institutional and federal guidelines, supporting the IRB’s mission to protect research participants; Manage the functions of IRB Secretariat; Periodic review and update IRB policies and procedures and disseminates information to all Research Investigators / Principal Investigators.
• IRB Protocol Approval Process: Review and process new research protocols, amendments, continuing reviews, and study closures submitted by researchers to ensure compliance with regulatory requirements and institutional policies; Post approval monitoring/conduct ERC Annual audit of the ongoing project; Validate documents with icddr,b’s IRB policies and guidelines; Provide feedback to applicants for completion of forms and other documents; Create agenda for review meeting and dispatch relevant material / protocols to committee members; Identify primary reviewers for protocols in consultation with respective chairs and share comments with members at the meetings; Share meeting observations with respective PIs and seek revised protocols; Review protocols to check for compliance with committee comments and resubmit documents to primary reviewers; Organize Expedited Review mechanism for urgent cases; Track approval of all protocols sanctioned by all concerned committees; Maintain a repository of all protocols pending, submitted and approved RRC / ERC / AEEC review in order to maintain adherence to the IRB guidelines in research protocols submitted by researchers.
• Facilitate IRB meetings: Organize and schedule IRB meetings, prepare agendas, coordinate with IRB members, and document meeting minutes; Ensure a quorum is met for each meeting; Organize retreats / special meetings; Update and maintain a list of committee members; Coordinate with NIH / relevant authorities to renew icddr,b’s registration with IRB Organisation (IORG), Federal Wide Assurance (FWA) and Animal Experimentation Ethics Committee (AEEC) to effectively implement activities of IRB process.
• Reporting: Prepare various reports, including annual reports, audit responses, and incident reports for icddr,b management, icddr,b Board of Trustees, IRB Board, Regulatory agencies, institutional officials, and for other purposes deemed necessary.
• Incident Management: Organize meetings of the Data and Safety Monitoring Board (DSMB) for incident investigation as necessary; Oversee logistics arrangements for DSMB members; Coordinate with Principal Investigator (PI) to submit the report to DSMB; a report to the ERC and Principal Investigator (PI); Advise PI on corrective action to coordinate effective investigations on research incidents.
• Training: Facilitate training for IRB members, researchers, and staff on the IRB review process, regulatory requirements, and ethical principles in human subject research. 

Required qualifications and experience:

• Master’s in Business Administration/Management/Public Health/Social Science or other relevant discipline.
• 8 – 10 years of experience, preferably in public health or research-based institutions. 
• Familiarity with research protocols and experience in reviewing the research protocols submitted by the researchers.
• Manage the Secretariat of the Institution Review Board (IRB) and facilitate meetings for the Research Review Committee, the Ethical Review Committee, the Animal Experimentation Ethics Committee, etc.
• Knowledge of research ethics and regulations governing human and animal subject research and clinical trials.
• Ability to work collaboratively and effectively with researchers, IRB members (Internal and External), Government agencies, and institution stakeholders.
• Capacity to identify and resolve issues related to research protocols or compliance.
• Ability to manage and prioritize multiple IRB submissions and deadlines.
• Strong written and verbal communication skills to interact with investigators, research staff, and IRB members.

Source:  https://career.icddrb.org/vacancy-preview/11995

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