Executive (Study Monitor), Office of Research Development and Scholarship

Broad Function

The Study Monitor is responsible for the oversight of clinical research for investigator initiated trials to ensure compliance with applicable regulatory standards, Human Biomedical Research Act (HBRA), Institutional Review Board (IRB) policies and hospital requirements. The Study Monitor will conduct site visits and remote monitoring in accordance with the study monitoring plan. He/She will also develop study monitoring plans as well as monitoring policies, work instructions and tools, etc. The Study Monitor is also responsible for identifying and escalating protocol deviations, noncompliance, and data discrepancies in order to ensure compliance with the study protocols and all applicable regulatory frameworks.

Key Responsibilities and Duties

Specific

• Perform on-site monitoring visits/remote monitoring for PI-initiated clinical trials in accordance with the study monitoring plan to ensure they are conducted, recorded and reported in accordance with the approved study protocol, applicable regulatory, IRB and hospital requirements.
• Develop a study monitoring plan for each study (e.g. percentage of records to be reviewed, frequency of review and plan for escalation of review).
• Communicate visit findings with site personnel and complete a written follow-up letter for distribution to the Principal Investigator and appropriate site personnel.
• Manage, coordinate and support study monitoring activities.
• Assist in initial and ongoing site personnel training as required.
• Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification review).
• Meet expected timelines for completion of monitoring activities and submission of written study monitoring reports.
• Provide guidance/advice in creating corrective and preventive action plans.
• Assist sites/study teams in audit readiness and preparation. Provide guidance/advice to study team in preparation for audits by reviewing all pertinent documentation and identifying gaps in required regulatory documents.
• Provide training to junior monitors.
• Perform regular review of study monitoring guidelines.

General

1. Attend NHG Quarterly Sharing session on monitoring.
2. Perform secretariat duties as assigned.
3. Other Ad hoc duties as assigned by Manager/Clinical Director, Office of Research Development & Scholarship.

Job Requirements

• University Degree, preferably in Life science.
• At least 3 years of clinical trial experience with monitoring experience.
• Good Knowledge of International Conference of Harmonisation Guidelines of Good Clinical Practice (ICGGCP) guidelines, local regulations and clinical research process.

• Good verbal and written communication skills.
• Mature, resourceful, detailed-oriented, self-driven and team player.
• Proficient in administrative skills and in Microsoft Office applications.
• Energetic and self-motivated with good organizational and inter-personal skills.
• Ability to multi-task and exercise discretion with confidential information.
• Ability to manage multiple projects at a time and work independently.

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