Research Compliance and Monitoring Officer

We are 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.