Clinical Research Coordinator (Jdhn-2019/08/23)

Location This post is based in Hanoi, Viet Nam. There will be a requirement to travel within Viet Nam to support projects, mainly in the northern region, and internationally to attend conferences.
Hours of work Full time Monday – Friday, 37.5 hours per week, extra hours may be required.
Tenure Initially for 01 years, including a 02 month probation period, with possibility of extension based on annual performance appraisal and research approval
Reporting to Clinical Trial Unit Manager / Director of OUCRU - HN
Vacancy reference JDHN-2019/08/23
Background The Oxford University Clinical Research Unit Vietnam (OUCRU-VN) is a large-scale clinical and public health research Unit based in Viet Nam. We are hosted by the Hospital of Tropical Diseases (HTD) in Ho Chi Minh City, and the National Hospital for Tropical Diseases (NHTD) in Hanoi. We also have have a sister units in in Kathmandu, Jakarta, Bangkok and Shantou, Indonesia. OUCRU is part of the Oxford Tropical Network with its major three hubs in Kenya, Thailand and Vietnam. As part of thea Wellcome Trust Major OverseasAsia Africa Programme, we have received considerable support from the Wellcome Trust since our establishment in 1991.

OUCRU’s ten-year vision is to have local, regional and global impact on health by leading a locally-driven research programme on infectious diseases in Southeast Asia. This is being achieved via an integrated long-term research programme, contributions to training, the scientific literature, national and international meetings and membership of national and international committees. Priority is given to health issues important to the hospitals, and to Viet Nam as a whole. All work is intended not only to benefit the patients seen daily at our host hospitals, but also to help improve patient care throughout Viet Nam and the region.


OUCRU was established in 2006 at the National Hospital of Tropical Diseases (NHTD). NHTD is a tertiary level teaching hospital, receiving infection related referrals from northern Vietnam and has close ties to the Ministry of Health (MoH).

Through its partnership with NHTD, OUCRU Hanoi also works with other hospitals and institutes in the region, including the National Institute for Hygiene and Epidemiology, the Vietnam National Children Hospital, the National Lung Hospital, Bach Mai Hospital, National Center for Veterinary Diagnosis, and other regional hospitals and health stations. The research programme at OUCRU Hanoi focuses on influenza, hospital acquired infections, and a range of laboratory, clinical, community and policy aspects of antimicrobial resistance. Through NHTD, OUCRU Hanoi has also been involved in consultations with MoH on antimicrobial resistance surveillance, national quality standards, antibiotic treatment guidelines, management of avian influenza and Streptococcus suis, and other public health issues. The main research interests for the Hanoi office are antimicrobial resistance and influenza. As part of our work on antimicrobial resistance we are partnering with the National Institute for Hygiene and Epidemiology to develop community-based interventions to change the way antibiotics are currently used, in order to reduce the emergence and spread of antibiotic resistance. We are looking for a social scientist with considerable experience using anthropological and/or qualitative research methods, and working with different communities in Vietnam.
Job summary A highly motivated Coordinator is required to work with Oxford University’sin our clinical trials unit (CTU) to work with OUCRU’s Principle Investigators (PIs) and local partners to coordinate and manage the implementation of OUCRU research projects across Vietnam, including both clinical trials and community-based studies; to support and develop the current research activities; to ensure efficient and high quality research operations in line with international standards; to contribute to the continued growth and development of the OUCRU’s research team portfolio in Vietnam and to be responsible for coordinating a number of trials and other studies across Viet Nam

Key tasks and responsibilities
• Collaborate Work with PI’s and local partner research institutions and hospitals to finalize Understand relevant clinical research protocols, and budgets, and other required documents associated data collection forms and consent forms regulatory requirements.during initial project start-up phase
• Support PI’s and local partners to prepare, submit and get ethical approval from local IRB committee(s) and/or other relevant international EC boards
• Develop standard operating procedures to control the quality of study implementation
• Organize logistics of study materials, including consumables, other studies’ materials and documents
• Closely supervise the implementation of the studies to ensure efficient and high quality research operation in line with international standards, including principles of Good Clinical Practice with clinical trials
• Supervise the conduct studies 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 and work with PI’s and local partner(s) to find sollutions as required.
• Liaise with sponsor for monitoring/audits. Write, file and collate trial documentation and visit reports with respect to monitoring.
• Develop the skills of a Clinical Research Monitor. Become a member of a team of Monitors responsible for verifying the quality and compliance of research projects.
• Visit other hospitals or community locations to deliver the above.
• Plan, implement and coordinate all aspects of data collection and entering management and cleaning, and storage, following OUCRU’s data management policy and ICH GCP guidelines if appropariate
• 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 with clinical trials.
• Translate study documents (Vietnamese - English – Vietnamese) if appropriate.
• 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.
• 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.
• Supervise the transfer of documents to the central OUCRU file server.
• 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 in clinical trials studies as per study protocol where appropriate.
• Organise, plan and co-ordinate ICH GCP training for local study staff in Hanoi and the region whenever needed.
• Train study staff and investigators in protocol relevant procedures including those for laboratory samples, data collection and recording, medication and patient assessment wherever it is appropriate.
• Support and participate in training of new CTU staff in OUCRU procedures pertaining to CTU duties.
• Participate in study team 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.
Selection criteria Essential Criteria:
• Medical Doctor, Public health, Pharmacy, nNurse or graduate with degree in Pharmacy, Science, Public Health or a related field.
• Good understanding of general ethical considerations applicable toy in research and good clinical practice (GCP) guidelines and other relevant regulations in conducting studies, including clinical trials
• Advanced level of English comprehensiond, including the ability to makedo translations from English to Vietnamese and vice versa
• Excellent interpersonal communication/diplomatic skills with people of different backgrounds and social positions Strong diplomatic skills.
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• Proven oral and written presentation skills.
• Excellent communication and interpersonal skills.
• High level of organizational and record keeping skills.
• Knowledge of ICH GCP guidelines.
• EXCELLENT VIETNAMESE and English language skills: listening, speaking, reading, writing.
Desirable Criteria:
• Master degree in clinical studies, epidemiology and public health or related fields Experience in conducting clinical trials compliant with ICH-GCP guidelines.
• Experience of working in a research institution with involvement in research protocol and data collection tools development and IRB submission Experience conducting or managing clinical trials
• Experience of monitoring/managing research/studies, including both clinical trials/research and community-based studies Industry experience
• Work experience of a Health Research Institution
• Experience in budgeting, monitoring budget and managing procurementMaster degree in health related field
Benefits
• Contracted salary: Negotiate (depending on actual experience and education)
• Optional insurance: In-patient and out-patient medical coverage; Personal accident insurance coverage
• 13th month salary (annual bonus)
• One month salary for annual clothes
• Annual leave 18 days/year (increased to 21 days in year three, 28 days in year four and 30 days from year five).
• Vietnam Social & Health insurance, Sick leave, Personal leave, Maternity leave and National holidays will be based on Vietnam Labor Law

How to apply
* Interested candidates are invited to send curriculum vitae, application and copies of relevant certificates, either by email or by post to
Oxford University Clinical Research Unit Vietnam
National Hospital for Tropical Diseases
78 Giai phong, Dong da, Ha noi
* The cover letter should detail: What part of your education, training or employment history has best equipped you for this position?
• - Why you would make a good candidate for this position?
- Names of two referees who can provide details of relevant experience
* Only short-listed candidates will be notified. Please no telephone contact after submitting the application
Contact person Ms. Bui Huyen Trang
Deadline for submission 06 September 2019

- Contracted salary: Negotiate

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