Assistant / Manager (Research Monitor), WH Office of Research Development and Scholarships

Broad Function

The Research Monitor is to lead and be responsible for overseeing the compliance, regulatory adherence and quality assurance aspect of all clinical research and regulatory related matters, including clinical trials regulatory submission and study monitoring activities.

This role needs to ensure proper study conduct and compliance with all applicable regulatory standards, Human Biomedical Research Act (HBRA), Institutional Review Board (IRB) policies, institutional requirements and perform risk-based monitoring strategies to uphold the integrity of clinical research.

Key Roles & Responsibilities

Specific

Monitoring

• Main institutional monitor responsible to implement risk-based monitoring strategies to uphold the integrity of clinical research and to oversee internal and external audits, inspections, and accreditation in relation to proper study conduct.
• At all times, to stay up to date and be able to interpret current local regulations, in relation to study conduct, to advise the management and to implement necessary adjustments to ensure institution’s compliance.
• Develop, plan, assign and conduct monitoring of research studies according to drafted study monitoring plan, and to ensure compliance towards the protocol, ICH-GCP, IRB guidelines, institutional policies and applicable local regulatory requirements. 
• Perform regular review and updates of study monitoring guidelines.
• Conduct routine monitoring visits, including site initiation, interim monitoring, and close-out visits.
  1. Perform source data verification and to ensure accuracy and integrity of the data collected
  2. Ensure safety, welfare and rights of the subjects are protected
  3. Ensure accountability and appropriate traceability of investigational products
  4. Compliance to all GCP, lRBs, regulatory and institutional SOPs requirements
  5. Writing up of monitoring report, issuance of follow up letters, actions and issues within the agreed timelines post monitoring.
  6. Appropriate escalation of issues for findings that impact research participants’ rights, welfare and well-being.
  7. Provide corrective and preventive actions (CAPA) for non-compliances
  8. Advise improvement and /or implement quality measures to address identified gaps
  9. Advise and support researchers to establish and to conduct studies to incorporates quality by design.
• Lead and manage the monitoring process to ensure adherence to protocols, patient safety and data integrity.
• Develop educational materials and workshops on clinical monitoring processes and quality assurance

Regulatory

• To be able to provide regulatory advice and submission plan to researchers and internal stakeholders.
• To be responsible and to perform timely regulatory submissions for regulated and non-regulated research studies, including but not limited to

(a) Clinical Trials Authorization (CTA)

(b) Clinical Trials Notification (CTN)

(c) Clinical Trials Certificate (CTC)

• Plan, conduct and to oversee all clinical trials to assess compliance and data quality
• Prepare study team for external regulatory inspections and sponsor audits
• Develop corrective and preventive action (CAPA) plans for audit findings and ensure timely resolution

Clinicaltrials.gov

• • To maintain clinicaltrials.gov portal and to ensure it is necessarily updated
  • To advise PIs in account-related matters and troubleshooting of issues as required.

Compliance

• Encourage and train researchers to be compliant with all applicable ethic guideline and regulatory requirement including institutional research policies
• Lead as champion for conducting quality research studies
• Actively contribute, lead and support the various research study audit activities at the institutional and cluster level.
• Keep up to date and be able to interpret current local regulations and advise accordingly on the possible of ramifications of regulatory changes. 
• Provide training/retraining/educate researchers on any compliance issues
• Promote proper research conduct culture
• Raise awareness of the required regulatory responsibilities of researchers
• Develop research initiative to promote and increase compliance

General

• To perform ad-hoc tasks and admin duties as assigned by the reporting officer.

Job Requirements

• Bachelor degree, preferably in Life science.
• At least 5 years of clinical research monitoring, regulatory compliance, or quality assurance
• Experience in healthcare settings will be advantageous
• Excellent knowledge of International Conference of Harmonisation Guidelines of Good Clinical Practice (ICGGCP) guidelines, local regulations and clinical research process
• Excellent 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
• Good interpersonal skills, a detail-oriented and flexible person who can work across different areas within the team & cross functionally outside the team
• Can-do attitude and ability to work independently, comfortable with ambiguity
• Thrive on problem solving, learning and apply new knowledge