Senior Executive, Research Compliance and Monitoring

Job description

The Singapore Eye Research Institute (SERI) is seeking a detail-oriented Research Compliance and Monitoring Officer to support the oversight and regulatory compliance of clinical trials and human biomedical research studies. This role plays a key part in ensuring studies are conducted in accordance with ICH-GCP, HBRA, HSA regulations, and institutional policies.

Key Responsibilities

Conduct routine and risk-based monitoring of investigator-initiated, HSA-regulated, and HBRA studies.

Review informed consent processes, protocol adherence, source documents, and CRFs to ensure data accuracy and participant safety.

Identify and document non-compliance, perform root cause analysis, and track corrective and preventive actions (CAPA).

Prepare monitoring reports, escalate significant findings, and support audit readiness.

Review study protocols, ICFs, CRFs, and essential documents for regulatory and GCP compliance.

Provide compliance guidance, reporting, and support to research teams and governance committees.

Contribute to GCP training, SOP development, and continuous quality improvement initiatives.

Requirements

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline.

Experience in monitoring HSA-regulated clinical trials.

Knowledge of ICH-GCP and the Human Biomedical Research Act (HBRA).

Strong attention to detail, good analytical skills, and ability to manage multiple studies.

Effective communication skills and ability to work independently and in multidisciplinary teams.