IRB Analyst

National Healthcare Group; Singapore; On-site; SGD 50,000 - 80,000; Full time

Job summary

A healthcare organization in Singapore seeks a Lead / IRB Analyst to ensure top-tier administrative support for research ethics. The role involves managing the Domain Specific Review Board operations, supporting the review and improvement of ethical guidelines, and ensuring timely and efficient review processes. Ideal candidates should have a degree in a relevant field, with at least 5 years of experience, particularly in an IRB setting. Strong organizational and interpersonal skills are essential.

Qualifications

• Minimum 5 years of relevant experience in an IRB setting.
• Good understanding of research ethics policies and regulations.
• Professional accreditation preferred, e.g. CIP.

Responsibilities

• Manage operations of the Domain Specific Review Board (DSRB).
• Assist in regular review and update of research ethical guidelines.
• Ensure timely processing of submissions and actions by review boards.
• Maintain DSRB-related reports and database.

Skills

Good organization skills

Project management skills

Data analytical skills

Good writing skills

Interpersonal skills

Team player

Education

Degree in Science / Life Sciences / Nursing / Pharmacy / Health Sciences

Job description

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