Clinical Research Coordinator (JDHAN_2020_09_010)

Department OUCRU - HN 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 JDHAN_2020_09_010 Background The Oxford University Clinical Research Unit Vietnam (OUCRU) 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 a sister unit in Jakarta, Indonesia. OUCRU is part of the Oxford Tropical Network with its major three hubs in Kenya, Thailand and Vietnam. As part of the Wellcome Trust Asia Africa Programme, we have received considerable support from the Wellcome Trust since our establishment in 1991. Our 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. Job summary A highly motivated Coordinator is required to work with in 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 and community-based studies; to ensure efficient and high quality research operations in line with international standards; to contribute to the continued growth and development of OUCRU’s research portfolio in Vietnam Key tasks and responsibilities · Work with PI’s and local partner research institutions and hospitals to finalize research protocols, budgets, and other required documents 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[HRvD1] the implementation of the studies to ensure efficient and high quality research operation in line with international standards, including principles of Good Clinical Practice · Track study progress and identify problems. Report to stakeholders as required and work with PI’s and local partner(s) to find solutions · Liaise with sponsor for monitoring/audits. Write, file and collate trial documentation and visit reports with respect to monitoring. · 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. · Supervise the transfer of documents to the central OUCRU file server. · Coordinate patient visit schedule in clinical 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, Nurse · Good understanding of general ethical considerations applicable to research and good clinical practice (GCP) guidelines and other relevant regulations in conducting studies, including clinical trials · Advanced level of English comprehension, including the ability to do translations from English to Vietnamese and vice versa · Excellent interpersonal communication/diplomatic skills with people of different backgrounds and social positions · Excellent Vietnamese language skills: listening, speaking, reading, writing. Desirable Criteria: · Master degree in clinical studies, epidemiology and public health or related fields · Experience of working in a research institution with involvement in research protocol and data collection tools development and IRB submission Experience of monitoring/managing research/studies, including both clinical trials/research and community-based studies · Experience in budgeting, monitoring budget and managing procurement 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 qualified candidates are invited to send their detailed resume and cover letter in English, including copies of relevant degrees, certificates by email to: trangbh@oucru.org * The cover letter should detail: - What part of your education, training or employment history has best equipped you for this position and why you would be a good candidate? - Contacts of two referees who are your latest HR/ line manager and can provide details of relevant work experience and attitude * We thank all applicants for their interest but only short-listed candidates will be contacted for interview. Contact person Ms. Bui Huyen Trang Deadline for submission 20th Sep 2020