Mô tả Công việc
OUCRU Hanoi - Clinical Trials Unit
Contract for one year on completion of 2-month probation with possibility for extension.
This job will be based at the National Lung Hospital, Vietnam National Children’s Hospital, OUCRU Hanoi
Hours of work
Full-time (37.5 hours per week Monday Friday)
Head of OUCRU-CTU-Hanoi
The Oxford University Clinical Research Unit (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 sister units in Kathmandu, and Jakarta. As a Wellcome Trust Major Overseas 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 employs approximately 320 people across Viet Nam and has an average annual budget of USD 12mil.
Please see more information on OUCRU Website : www.oucru.org.
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.
The post-holder will be based in Ha Noi and co-ordinate the SURE trial at the two study sites; National Lung Hospital and National Children’s Hospital.
The SURE trial is an internationally-led randomised controlled trial evaluating shortened, intensified antituberculosis and anti-inflammatory therapy for children with TB meningitis.
The post-holder will be part of a large project team which includes a TB project manager and senior study coordinator at OUCRU-CTU in Ho Chi Minh City and will be responsible for the day-day study operations in Ha Noi.
Yêu Cầu Công Việc
Key responsibilities and tasks
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 plan, implement and coordinate all aspects of data collection and entering management and cleaning, and storage, following relevant data management policy and ICH GCP guidelines if appropariate
Ensure adequate supply and logistics of study materials including files test kits, patient samples, data entry log, pharmacy supplies, stationery and other research materials
Liaise with key collaborators (study doctor, study nurse and hospital coordinators), and arrange study training and regular team meetings.
The study coordinator is expected to take meeting minutes and follow up on action points in a timely manner.
Prepare and manage study invoices (hospital fee invoices, telephone invoices, labor cost invoice, travel reimbursment invoice, etc) as per training.
Ensure that screening, SAE and EOI logs are accurately completed and updated every week and send these logs to OUCRU CTU.
Review study CRFs, ensure CRF completion at both sites (NLH and NCH) and raise missing data queries to study doctors.
Scan the completed page of CRF and send to OUCRU CTU HCM for data entry using secure emailing.
Review completed and signed ICF and / or AF to ensure correctly completed as for good clinical practice.
Notification of SAE reports to local EC and MoH in a timely manner. If any SAEs are identified during CRF checking process, the coordinator is to raise the query with study doctor and provide support when necessary.
Manage the tracking file for study scheduled visits, SAE report.
Liaise with sponsor for monitoring / audits. Write, file, and collate trial documentation and visit reports with respect to monitoring.
Liaise with international collaborators as needed. This includes attendance, participation at TMG meetings with sponsors and other international study sites, and preparation for IDMC meetings when requested by study sponsors.
Verify finance supporting documents for payment.
Translate study documents (Vietnamese - English Vietnamese) if appropriate.
Supervise the transfer of documents to the central OUCRU file server.
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.
Track study progress (number of patients screened, and recruited on a weekly basis) and identify problems at the study site.
Report to Project manager as required.
Work closely with laboratory staff to generate a list of stored samples from enrolled patients, using the laboratory sample log and checklist.
Facilate transfer of samples to external sites when requested.
Work closely with site pharmacist to check the study drug prescription, study drug accountability.
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.
Good comprehension and regular review of clinical research protocols, Site SOPs and regulatory requirements
Basic science degree
Minimum of 1 year of research experience
Excellent skills in verbal and written communication
Ability to work closely with other study staff and hospital collaborators
Good attention to detail in following protocols, SOPs and record keeping
Proficiency with computers, specifically Microsoft Word and Excel
Interest in clinical and / or epidemiological research
Excellent Vietnamese and good English language skills
Excellent interpersonal skills
Exemplary organizational and time management skills
Prior experience in clinical research (e.g. clinical trials)
Proficiency with database programs
Understanding of academia, research or not-for-profit working environment
Previous work experience with a research ethics team
Good clinical practice (GCP) certification
Contracted salary : Negotiable (depending on actual experience and education).
Optional insurance : In-patient and out-patient medical coverage; Personal accident insurance coverage
Two months’ salary for annual bonus and clothes
Annual leave 18 days each year for the first year
Other responsibilities and benefits are based on Viet Nam Labour 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 Ms Pham Thi Thanh Hoa, operations manager OUCRU Hanoi.
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.
Ms. Pham Thi Thanh Hoa
Deadline for submission
Thông tin khác
Bằng cấp : Đại học
Độ tuổi : Không giới hạn tuổi
Hình thức : Nhân viên chính thức