Job Description

Family Group: Administration
The Lead / IRB Analyst needs to ensure that the NHG Office of Human Research Protection Programme (OHRPP) provides the highest level of administrative support services for ethics, thereby ensuring the sustainability of a robust and effective research ethics review process.



The Lead / IRB Analyst will assist the Manager to manage the operations of the Domain Specific Review Board (DSRB) to ensure that they meet their primary responsibilities of protecting the rights and welfare of human research subjects.



1. Ethics Policy Management



1.1 Assists the Manager in regular review and update of research ethical guidelines, policies and standard operating procedures.



1.2 Perform secretariat duties to the NHG REC.



2. Ethics Review and Approval Process and Procedures



2.1 Monitoring of Quality of Review



Ensures that research protocols submitted to functional teams are reviewed efficiently and consistent with the applicable regulations, guidelines and policy

Ensures that the Review Board's reviewing processes are properly conducted, including meeting agendas, ensuring quorum, and document minutes of the meetings and follow up actions including correspondence to Investigators/ Sponsors.

Ensures that meeting minutes are in sufficient details to document Review Boards' deliberations.


2.2 Monitoring of Timeliness of Review



Screens and audits applications and correspondence received by the review boards in functional team and assist to oversee the accurate and timely processing, of submissions to and actions by the review boards.



2.3 Participate in Quality Improvement



Improve ethics approval process and effectiveness of review, as part of continuous improvement project



2.4 Serve as resource for Investigators and Researchers regarding the adaptation and implementation of DSRB policies, procedures and forms.



2.5 Effectively communicate and document all communications with Sponsors, Investigators, Review Board Members and regulatory authorities.



3. DSRB Database Management



Assists in preparing DSRB-related reports on ethics and other topics

Maintains an accurate, comprehensive and up-to-date database of all applications.


4. Operational Matters of Administrative Support Office



Performs operational matters in the absence of the IRB Manager/Assistant Manager

Performs any other ad-hoc job-related duties as assigned.

Serve as the Main Secretariat of Ethics conferences/programs.

JOB REQUIREMENTS

Education/Training/Experience

Degree, preferably in Science / Life Sciences / Nursing / Pharmacy / Health Sciences Minimum 5 years of relevant experience, preferably in an IRB setting. Experience in healthcare, clinical research and related training would be an advantage. Displayed a good understanding of research ethics policies and local regulations Professional accreditation preferred e.g. CIP Demonstrate basic knowledge and skills in quality and process improvement approaches Possess good organization, project management and preferably with data analytical and good writing skills

Personal Attributes

Demonstrated good inter-personnel and influencing skills in working with different groups of stakeholders Team-player, demonstrates excellent team spirit and skills in supporting teams and managers Ability to influence and motivate people * Ability to handle and manage stressful situations and work independently under pressure