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National Healthcare Group Corporate Office is seeking a dedicated professional to support the Ethics Review and Approval processes. You will assist in drafting guidelines, act as the REC secretariat when appointed, and ensure minutes and literature are well-documented.
The role involves maintaining the DSRB database, supporting qualitative improvement, and coordinating cross-domain activities. You will collaborate with investigators and sponsors, communicate with regulatory authorities, and help
1.1 Assists the Manager in preparation, regular review and update of research ethical guidelines, policies and standard operating procedures.
1.2 Perform secretariat duties to the NHG REC, if appointed.
1.3 Ensures that REC meeting minutes are in sufficient details to document board's deliberations.
0.1FTE
Preparation of at least 1 REC paper per year.
Support REC led initiatives.
(a) Ensures that research protocols submitted to assigned Domain are reviewed efficiently and consistent with the applicable regulations, guidelines and policy
(b) 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.
(c) Ensures that meeting minutes are in sufficient details to document review boards' deliberations.
0.3FTE
Timely and effective follow ups of Domain work to ensure that Domain is conducting reviews appropriately.
Specific Deliverables:
(a) Screens and reviews applications and correspondence received by the review boards and to oversee the accurate and timely processing, of submissions to and actions by the review board.
(b) Manage Domain operations and meetings
0.3FTE
Timely and effective follow ups of Domain work to ensure that Domain work are conducted timely.
To participate and engage in quarterly monitoring exercise on studies with long TAT.
Specific Deliverables:
Specific Deliverables:
Improve ethics approval process and effectiveness of review, as part of continuous improvement project
0.1FTE
Participate actively in discussions and lead 1 improvement initiative
2.5 Effectively communicate and document all communications with Sponsors, Investigators, review board members and regulatory authorities.
0.1FTE
Give timely advice and effective resolution of concerns/feedback from investigators across Institutions
3.1 Assists in preparing DSRB-related reports on ethics and other topics.
3.2 Maintains an accurate, comprehensive and up-to-date database of all applications.
0.05FTE
Be able to discern and capture information in reports.
Be accurate in reports.
4.1 Be involved in cross coverage plans for other Domains
4.2 Performs any other ad-hoc job-related duties as assigned.
4.3 Serve as the Secretariat of Ethics conferences/programs.
0.05FTE
Be able to provide sufficient coverage for other Domains when help is requested.
Demonstrate good team-work and willingness to handle Ad-hoc tasks without compromising the quality of the core-function.
Bachelor's Degree