JOB SUMMARY
The recent, impressive growth in clinical trials capacity and opportunity needs to be matched with trained and qualified clinical research staff to ensure efficient and high quality research operations in line with international standards. The post of Clinical Research Coordinator is required to execute new and ongoing research projects.
GENERAL RESPONSIBILITIES
The post holder will be responsible for supporting and developing the overall research activities of OUCRU-VN including the following tasks:
Coordinate all regulatory, logistical, training and reporting tasks associated with running a clinical study/trial.
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.
Liaise with colleagues in pharmacy, monitoring, data management and laboratory departments to ensure quality and harmonious execution of study procedures.
Train study staff and investigators in protocol relevant procedures.
Execute study-related administrative tasks, such as collection of data and regulatory documents, 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.
Track with the study team about the schedule of shipping samples to make sure all samples are sent on time.
Supervise the conduct of the study to ensure compliance with the principles of Good Clinical Practice applicable local and international regulatory standards.
Involve visiting the study sites in provinces frequently (monthly or depend on the study recruitment rate).
Track study progress and identify problems. Report to the Principal Investigator 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.
Understand relevant clinical research protocols and regulatory requirements.
Translate study documents (Vietnamese - English – Vietnamese).
Attend career training to improve skills and update relevant knowledge.
Other tasks as required.
DEPARTMENT
Malaria Group and Clinical Trials Unit
LOCATION
This post is based in Ho Chi Minh City, Viet Nam. Travel to hospitals or units around Ho Chi Minh City will be required regularly. Travel within Viet Nam or internationally will be required.
HOURS OF WORK
Full time (37.5 hours per week from Monday to Friday)
TENURE
Initially for one year, including a 2 month probation period, with possibility of extension.
REPORTING TO
Head of Clinical Trials Unit
