Sr/Executive (DSRB) - Temp

National Healthcare Group; Singapore; On-site; SGD 70,000 - 95,000; Full time

Job summary

A leading healthcare organization in Singapore seeks a Lead IRB Analyst to assist in managing operations of Domain-Specific Review Boards. Ideal candidates have at least 5 years of relevant experience in an IRB setting, possess a degree in Science or related fields, and demonstrate excellent organizational and interpersonal skills. This role involves monitoring junior Analysts, approving ethical guidelines, and liaising with stakeholders.

Qualifications

• Minimum 5 years of relevant experience in an IRB setting.
• Professional accreditation preferred e.g. CIP.
• Demonstrate basic knowledge in quality and process improvement.

Responsibilities

• Assist Manager in managing Domain-Specific Review Boards.
• Monitor work of junior Analysts and allocate resources.
• Review and update ethical guidelines and standard operating procedures.

Skills

Research ethics policies understanding

Inter-personnel and influencing skills

Organizational skills

Project management skills

Data analytical skills

Good writing skills

Education

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

Job description

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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 include 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.

Ethics Policy Management

1. 1.1 Assists the Manager in regular review and update of research ethical guidelines, policies and standard operating procedures.
2. 1.2 Perform secretariat duties to the NHG REC.
3. 1.3 Assists in supervising administrative support staffs for ethics, which includes work allocation and problem resolution for their functional team.

Ethics Review and Approval Process and Procedures

1. 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. 2.2 Monitoring of Timeliness of Review
3. 2.3 Participate in Quality Improvement
   • Improve ethics approval process and effectiveness of review, as part of continuous improvement project
4. 2.4 Serve as resource for Investigators and researchers regarding the adaptation and implementation of DSRB policies, procedures and forms.
5. 2.5 Effectively communicate and document all communications with Sponsors, Investigators, review board members and regulatory authorities.

Training & Monitoring of Analyst performance

1. 3.1 To orientate and train new Analysts to competency in reviewing studies independently.
2. 3.2 To train and ensure new Analysts have an appreciation of the rationale behind application forms and questions.
3. 3.3 To review studies as part of continuing development and to maintain relevance in practice (for discussion)

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.

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, 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