Assistant Manager

Job Description

Researchers in Duke-NUS are required to comply with a wide range of statutory regulations and ethical guidelines. These include rules relating to research using animals, human subjects and tissues, data management and the requirements associated with the responsible conduct of research at Duke-NUS.

We are looking for a candidate to manage the Duke-NUS Secure Data and Tissue Repositories, as well as conduct evaluations on compliance with relevant guidelines and legislation, including the Human Biomedical Research Act (HBRA) for human subject research studies. The candidate will also promote and support continuous best practices in identifying process deficiencies and implementation of corrective action plans.

• Provide quality support to research departments within the School to ensure and enhance their compliance with research ethics, particularly HBRA through  identifying process deficiencies, sharing best practices and assisting with  development/enhancement of standard operating procedures, policies and processes.
• Manage a centralised digital and hardcopy human subject research identifiers (HSRI) for data and tissues. This includes safekeeping and archival of HSRI according to HBRA and Personal Data Protection Act (PDPA) requirements and ensure due process for requests to access HSRI.
• Review requirements and manage Institutional endorsements for Duke-NUS collaborative research studies in the Ethics and Compliance Online System (ECOS) platform
• Perform random internal audits to determine compliance with established and approved written procedures, internal guidelines and legal requirements.
• Work with the audited research unit to resolve discrepancies and enhance compliance and productivity.
• Report, follow up and verify that identified corrective/preventive actions have been implemented.
• Serve as the secretariat to meetings conducted by the Research Ethics, Integrity and Compliance unit
• Undertake any other quality assurance responsibilities and tasks.

Qualifications

• Degree in Biology, Pharmacy or other Life Sciences discipline.  
• Minimum 4 to 6 years of relevant experience in conducting research regulated under HBRA.
• Prior experience in handling clinical research quality assurance, compliance and auditing related matters as well as on-site/off-site routine monitoring under Good Clinical Practice ICH E6 (R2) standards would be advantageous.
• Possess effective interpersonal communications with strong writing and presentation skills as well as problem-solving abilities.
• Able to proactively engage and manage internal stakeholders as well as external stakeholders and collaborators.
• Able to work well independently and with others, perform under pressure and adhere to timelines.
• Proficient in general software applications that facilitate work operations such as Microsoft Office, REDCap, Qualtrics and other data management programmes.

We regret that only shortlisted candidates will be notified.