JOB SUMMARY
The recent, impressive growth in clinical trials capacity and opportunity at OUCRU needs to be matched with high-level research governance and operation to ensure safe and high quality research in line with international standards. The post-holder, is required to execute new research projects and contribute to the continued growth and development of the CTU team.
KEY TASKS AND RESBONSIBILITIES
The post-holder will be based within the OUCRU-VN Clinical Trials Unit and have key tasks and responsibilities below:
• Maintain an up-to-date understanding of the applicable trial regulations, both local and international, train investigators on regulatory changes and ensure that these standards are implemented in all research managed by the CTU.
• Implement the Unit’s policies on the conduct of clinical trials.
• Contribute to the development of quality and efficiency within the CTU.
• Coordinate all regulatory, logistical, training and reporting tasks associated with running a clinical study/trial.
• Liaise with colleagues in pharmacy, monitoring, data management and laboratory departments to ensure quality and harmonious execution of study procedures.
• Be a part of a team that provides training for senior hospital staff on the ICH guidelines of Good Clinical Practice.
Key duties/tasks:
• Understand relevant clinical research protocols and regulatory requirements.
• Translate study documents (Vietnamese - English – Vietnamese).
• Develop standard operating procedures to control the quality of study conduct.
• Organize logistics of study materials including drugs, files, test kits, patient samples, data and other materials.
• Plan, implement and coordinate all aspects of data collection, recording and source documentation, as per hospital and unit policy and ICH/GCP guidelines.
• Train study staff and investigators in protocol relevant procedures including those for laboratory samples, data collection and recording, medication and patient assessment.
• Execute study-related administrative tasks, such as collection of data and regulatory documents, managing reimbursement for patients and study staff, filing or retrieving files, maintaining patient charts and supply inventories, etc.
• Verify that data entered on to the CRFs is complete and consistent with patient clinical notes, known as source data/document verification.
• Coordinate patient visit schedule as per study protocol.
• Supervise the conduct of the study to ensure compliance with the principles of Good Clinical Practice, which will involve visiting the study sites on a regular basis.
• Track study progress and identify problems. Report to stakeholders as required.
• Liaise with sponsor for monitoring/audits. Write, file and collate trial documentation and visit reports with respect to monitoring.
• Organize and participate in group meetings to share experience and contribute to the knowledge of others in the team.
• Attend career training to improve skills and update relevant knowledge.
• Other tasks as required.
DEPARTMENT
Clinical Trial Unit (CTU)
LOCATION
This post is based in OUCRU Ho Chi Minh City.
HOURS OF WORK
Full-time
TENURE
This is a 1 year contracted position with possibility of extension to 36 months
REPORTING TO
Head of Clinical Trials Unit
