Specialist (Part Time), Group Research
Institution:
National Healthcare Group
Family Group:
Administration
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Specialist (Part Time) Department: Group Research NHG HQ
Job Description : |
| Job Description of NHG Domain Specific Review Board (DSRB) Member (Part-Time) 1. JOB PURPOSE The NHG Domain Specific Review Board (DSRB) is an independent committee constituted of medical, scientific and non-scientific members. The DSRB’s responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in research studies conducted by NHG or its partner institutions by reviewing, approving, and providing continuing review of research studies, protocols and amendments, and of the methods and materials to be used in obtaining and documenting informed consent of the research subjects. As a DSRB Member (Full-Time), you will be a key member of the DSRB who complements the DSRB ethics review system by reviewing and approving studies and submissions that can be reviewed via the expedited review route (e.g. when the study involves no more than minimal risk or when the Board has determined that there are only minor changes required), thus enabling the approval turnaround times to be shortened so that research teams can commence their studies earlier. You will be equipped to review studies across all the DSRB Domains (i.e. not limited to selected disease specialties), whereby the assignment shall be adjusted according to operational needs. This provides opportunities for you to interact with many senior and experienced DSRB Chairpersons and Members, as well as renowned clinician-leaders and clinician-scientists from different specialties, and be able to contribute greater towards the advancement of clinical research while maintaining high standards of human subjects’ protection in Singapore. You will also play an essential role in the formulation and improvement of DSRB policies and processes, and provide advice and guidance to principal investigators, study teams and other stakeholders on compliance with applicable regulations, DSRB policies and reporting requirements, guidance documents etc. You will receive a formal appointment letter from NHG and each Research Institution which has engaged the NHG DSRB ethics review services, as required by the Human Biomedical Research Act (HBRA). For individuals who are looking for a more flexible work arrangement, this position will allow you the flexibility to plan your work schedule as the reviews are done using an online system and meetings can be arranged accordingly. 2. MAJOR DUTIES & RESPONSIBILITIES Reviews and approves new studies and submissions (expedited review route) as assigned, and ensures that they are reviewed efficiently and consistent with the applicable regulations, guidelines and policies. Communicates and documents all communications with principal investigators, study teams, sponsor representatives and regulatory authorities. Contributes to the formulation and improvement of DSRB policies and processes. Provides advice and guidance to principal investigators, study teams and other stakeholders on compliance with applicable regulations, DSRB policies and reporting requirements, and guidance documents etc. Ensures reviews and decisions are documented sufficiently and maintained properly for audits. Works with the DSRB Secretariat to ensure the accuracy of outcome letters, maintaining records and documentation through filing, compilation and archiving. Keeps abreast of regulations and policies pertaining to human subjects’ research by attending relevant training and continuing education platforms. Performs any other ad-hoc job-related duties as assigned. 3. JOB REQUIREMENTS (a) Education/Training/Experience
(b) Personal Attributes
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