Manager, Research Compliance

The primary objective of this job role is to enable proactive monitoring of research activities in NTU, ensuring compliance with legal and regulatory requirements (e.g., Personal Data Protection Act, Human Biomedical Research Act, Animal and Birds Act) as well as research-related institutional policies and procedures (PnPs) focused on human subject research. Additionally, the position will support other initiatives (e.g. Research Integrity, Research Data Management, Research Protection & Safeguards) aimed at fostering responsible and ethical research practices among NTU researchers.

Key roles & responsibilities for this role:

• Support the development, updates and implementation of PnPs required under the Human Biomedical Research Act (HBRA), the Animal and Birds Act (ABA), the Personal Data Protection Act (PDPA) and by NTU.
• Support the proactive monitoring of approved research studies involving either humans and/or animals through regular compliance monitoring audits.
• Assist in the generation of formal reports of monitoring activities and highlight inadequacies to research teams and management for remedial actions and follow-up.
• Facilitate and monitor the implementation of corrective and preventive actions to address detected non-compliances.
• Assist in the investigations of non-compliances to IRB / IACUC approved protocols, follow-up on incidences of safety or adverse events, and timely reporting to NTU Management and regulatory agencies where necessary.
• Facilitate and monitor the implementation of corrective and preventive actions to address the reported incident.
• Facilitate collaborations with internal stakeholders (e.g. IAO, ERM, LSO, RSO, PO etc. ) to address compliance matters related to research regulations and PnPs.
• Keep abreast on legal and regulatory changes that could impact research activities in NTU and serve as the point-of-contact for NTU researchers, other study personnel and administrators on research PnPs in NTU, including addressing enquiries and communicating updates to NTU researchers.
• Maintain proper documentation and systematic filing of Research Compliance documents.
• Provide administrative support for meetings including (but not limited to) taking minutes of meeting.
• Proactively monitor the completion rates for mandatory research integrity training in NTU and generate relevant reports to notify management on follow-up actions where necessary.
• Assist in the update of training programs and materials to educate NTU researchers on Research Integrity.
• Serve as one of the point-of-contact for NTU faculty members and researchers on research integrity matters in NTU, including addressing enquiries and communicating updates to them.
• Maintain proper documentation and systematic filing of research integrity training documents.
• Provide administrative support for research integrity events and meetings including (but not limited to) taking minutes of meeting.

Educational Qualification(s) & Experiences required:

• Minimum Bachelor's Degree, preferably in a biomedical related or health sciences field and/or related areas from an accredited university.
• Min 3 years or more working experience in Research-related or higher education industry.
• Experienced in research administration/ research ethics/ research compliance/ regulatory affairs/ quality assurance would be an advantage.
• Possess strong oral and written communication and people skills to support the management of cross-functional, institutional relationships and ability to multitask.
• Proficient in Microsoft Office applications, Acrobat applications, and knowledge of Research Management Systems.
• Good team player with strong sense of ownership.
• Able to work with a high degree of accuracy and attention to details.

We regret that only shortlisted candidates will be notified.

Hiring Institution: NTU

The primary objective of this job role is to enable proactive monitoring of research activities in NTU, ensuring compliance with legal and regulatory requirements (e.g., Personal Data Protection Act, Human Biomedical Research Act, Animal and Birds Act) as well as research-related institutional policies and procedures (PnPs) focused on human subject research. Additionally, the position will support other initiatives (e.g. Research Integrity, Research Data Management, Research Protection & Safeguards) aimed at fostering responsible and ethical research practices among NTU researchers.

Key roles & responsibilities for this role:

• Support the development, updates and implementation of PnPs required under the Human Biomedical Research Act (HBRA), the Animal and Birds Act (ABA), the Personal Data Protection Act (PDPA) and by NTU.
• Support the proactive monitoring of approved research studies involving either humans and/or animals through regular compliance monitoring audits.
• Assist in the generation of formal reports of monitoring activities and highlight inadequacies to research teams and management for remedial actions and follow-up.
• Facilitate and monitor the implementation of corrective and preventive actions to address detected non-compliances.
• Assist in the investigations of non-compliances to IRB / IACUC approved protocols, follow-up on incidences of safety or adverse events, and timely reporting to NTU Management and regulatory agencies where necessary.
• Facilitate and monitor the implementation of corrective and preventive actions to address the reported incident.
• Facilitate collaborations with internal stakeholders (e.g. IAO, ERM, LSO, RSO, PO etc. ) to address compliance matters related to research regulations and PnPs.
• Keep abreast on legal and regulatory changes that could impact research activities in NTU and serve as the point-of-contact for NTU researchers, other study personnel and administrators on research PnPs in NTU, including addressing enquiries and communicating updates to NTU researchers.
• Maintain proper documentation and systematic filing of Research Compliance documents.
• Provide administrative support for meetings including (but not limited to) taking minutes of meeting.
• Proactively monitor the completion rates for mandatory research integrity training in NTU and generate relevant reports to notify management on follow-up actions where necessary.
• Assist in the update of training programs and materials to educate NTU researchers on Research Integrity.
• Serve as one of the point-of-contact for NTU faculty members and researchers on research integrity matters in NTU, including addressing enquiries and communicating updates to them.
• Maintain proper documentation and systematic filing of research integrity training documents.
• Provide administrative support for research integrity events and meetings including (but not limited to) taking minutes of meeting.

Educational Qualification(s) & Experiences required:

• Minimum Bachelor's Degree, preferably in a biomedical related or health sciences field and/or related areas from an accredited university.
• Min 3 years or more working experience in Research-related or higher education industry.
• Experienced in research administration/ research ethics/ research compliance/ regulatory affairs/ quality assurance would be an advantage.
• Possess strong oral and written communication and people skills to support the management of cross-functional, institutional relationships and ability to multitask.
• Proficient in Microsoft Office applications, Acrobat applications, and knowledge of Research Management Systems.
• Good team player with strong sense of ownership.
• Able to work with a high degree of accuracy and attention to details.

We regret that only shortlisted candidates will be notified.

Hiring Institution: NTU