Full Time Quality Assurance Specialist (Clinical Research) Jobs, in Sunway Medical Centre Selangor - Maukerja

Job Summary

· Ensuring Quality Assurance (QA) across the Clinical Research Centre (CRC) and Clinical Trial Ward through developing, implementing and maintaining policies, systems and processes for clinical research, both industry-sponsored and investigator-initiated research, undertaken across the organisation.

· Responsible for monitoring, performing and coordinating audits, and reporting of quality-related matters, to the hospital management and relevant stakeholders, in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP) principles, Malaysian Society for Quality in Health (MSQH) standard, The Australian Council on Healthcare Standards (ACHS), Joint Commission International (JCI) standard, National Pharmaceutical Regulatory Agency (NPRA) guidelines, Malaysian Guideline for Phase I Unit Inspection and Accreditation Programme, and Cawangan Kawalan Amalan Perubatan Swasta (CKAPs).

Key Accountabilities

Quality Assurance & SOP Maintenance

· Ensure compliance with applicable Good Clinical Practices (GCPs) through training, processes, and proactive identification and correction of issues

· Plan and conduct regular audits of processes and systems for clinical research activities, and make recommendations to the department for improvements to ensure ongoing regulatory compliance

· Draft, maintain, review and revise SOPs as needed and according to the SOP review schedule

· Review and provide recommendations on Corrective Action/ Preventive Action (CAPA) on protocol deviations and serious adverse events reporting

· Work closely with the Sunway Medical Research Ethics Committee on initiatives to improve quality of delivery of clinical research projects and safeguarding the rights, safety and well-being of the research participants

· Monitor, compile, analyze, and report quality improvement plan and risk register of the department to the hospital’s quality resources and management team

· Assist in document control activity as per Quality Resource (QR) Department requirements

Audit & Accreditation

· Plan and perform internal audits of clinical research projects in collaboration with the regulatory compliance and ethics team

· Work with the regulatory compliance and ethics team to coordinate external audits on clinical research projects, e.g., by sponsors, local or international regulatory bodies

· Lead the preparation for mandatory inspection and audit of the Clinical Trial Ward by the NPRA, ensuring that all SOPs and application materials are in place, to achieve Phase I Accreditation

· Organise and lead mock inspections of the Clinical Trial Ward in cooperation with the clinical team members

· Work collaboratively with the hospital’s Quality Assurance team to coordinate audit inspection by the hospital’s accreditation bodies e.g., MSQH, ACHS, JCI, etc.

Training and quality improvement initiatives

· In partnership with the CRC Team, monitor and audit mandatory research training (GCP, GCP Refresher, NPRA Regulations etc.) for staff, to ensure that training records are updated and made readily available for scrutiny by regulatory authorities

· Perform training need analysis and identify gaps and opportunities to improve the team quality and efficiency through internal and external training initiatives

· Provide training to the department personnel regarding new SOP implementation, quality of research delivery, and accreditation

· Maintain the training log of the departmental personnel and promote Promotes culture of continuous process improvement.

· Plan and orientate new personnel on quality assurance-related matters

Others

· Perform any other tasks/duties as assigned by management

Job Requirements

• Bachelor's Degree in Biomedical Science, Pharmacy, Nursing or closely related fields.
• Preferably 1-3 years of working experience in Clinical Quality Assurance and/or Clinical Trials.
• GCP Certification.
• Practical experience of monitoring clinical trial activity or practical experience in clinical research or direct involvement in the management/administration of clinical trials.
• Experience of managing, developing and implementing quality assurance systems and processes (preferred).
• Experience in hosting or participating in regulatory inspections or conducting audits (preferred).

Required Skills

• Excellent verbal and written communication skills.
• Good organizational and time management.
• Commitment to teamwork.
• Diplomatic and calm under pressure.
• Commitment to learning and continuous improvement.
• Expected to work under limited supervision with considerable latitude for the use of initiative and independent judgment.
• Meticulous attention to details.
• Proven ability to prioritize workload and meeting deadlines.