Sr Executive

at  National Healthcare Group

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, 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

The Lead 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 Boards to ensure that they meet their primary responsibilities of protecting the rights and welfare of human research subjects. The responsibilities of the Lead Analyst includes monitoring the work of the junior Analysts, allocation of resources to support the functions of each Domain, training and mentoring of new Analysts, and assisting the IRB Manager in implementing IRB specific policies.
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.
1.3 Assists in supervising administrative support staffs for ethics, which includes work allocation and problem resolution for their functional team.
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. Training & Monitoring of Analyst performance
3.1 To orientate and train new Analysts to competency in reviewing studies independently.
3.2 To train and ensure new Analysts have an appreciation of the rationale behind application forms and questions.
3.3 To review studies as part of continuing development and to maintain relevance in practice (for discussion)

1. 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.

1. 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.