DSRB Lead Analyst, Office of Human Research Protection Programme (OHRPP)

Job Purpose

The DSRB Lead Analyst needs to ensure that the NHG Health 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 DSRB Lead 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 ReviewEnsures that research protocols submitted to functional teams are reviewed efficiently and consistent with the applicable regulations, guidelines and policyEnsures 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 ReviewScreens 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 ImprovementImprove 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

4. DSRB Database ManagementAssists in preparing DSRB-related reports on ethics and other topicsMaintains an accurate, comprehensive and up-to-date database of all applications

5. Operational Matters of Administrative Support OfficePerforms operational matters in the absence of the IRB Assistant Director/Senior Manager/ManagerPerforms any other ad-hoc job-related duties as assignedServe as the Main Secretariat of Ethics conferences/programs

JOB REQUIREMENTS

Education/Training/Experience

• Degree, preferably in Science / Life Sciences / Nursing / Pharmacy / Health SciencesMinimum 5 years of relevant experience, preferably in an IRB setting.
• Experience in healthcare, research and related training (e.g. CITI and GCP training) would be an advantage, especially if it includes experience in conducting clinical research in Public Healthcare Institutions.
• Displayed a good understanding of research ethics policies and local regulations
• Professional accreditation preferred e.g. Certified IRB Professional (CIP)
• Demonstrate basic knowledge and skills in quality and process improvement approaches
• Possess good organization, project management and preferably with data analytical and strong communication (written and verbal) skills

Personal Attributes

• Demonstrated good inter-personal 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 peopleAbility to handle and manage stressful situations and work independently under pressure