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Clinical Trial Unit Manager

Oxford University Clinical Research Unit

Địa điểm làm việc: Hà Nội
Hết hạn: 21/04/2019

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Mô tả công việc

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
• Director of OUCRU - HN
Vacancy reference
• 2019/03/29 - MAN.
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 sister units in Kathmandu, Jakarta, Bangkok and Shantou. As a Wellcome Trust Major Overseas Programme, we have received considerable support from the Wellcome Trust since our establishment in 1991.
• OUCRU - VN aims to have a positive and significant impact on global health and, in particular, the prevention, diagnosis and treatment of infectious diseases. 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.
• 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
• The ongoing expansion and growth in research and involvement in national policy development at OUCRU-Hanoi has led to the funding of new positions with our clinical research team.
• We are recruiting to the post of Clinical Research Manager to meet the challenge of this expansion and to execute and support new and ongoing research projects, including randomized controlled trials, large scale observational studies and the development of national services in collaboration with national bodies, including an antimicrobial resistance reference laboratory and serum bank.
• The post-holder will also play a key role in all aspects of research governance and support including protocol generation, IRB submission, control and management of regulatory documents, data management and development and supervision of other staff responsible for coordinating and monitoring OUCRU studies.
• He/she should be pro-active and ensure the work is of high standard.
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

Yêu cầu

Selection criteria
• Supervise a team of clinical research coordinators
• Develop/supervise the development of standard operating procedures and logistical plans for the implementation of clinical trials and other study designs in liaison with Clinical Trials Unit (CTU) OUCRU-HCMC
• Oversee protocol and CRF development and implementation and ensure correct Vietnamese translations.
• Liaise with staff at CTU OUCRU-HCMC to ensure that documentation and approaches are streamlined and congruous.
• Act as focal point in liaison with regulators, ethical committees and CTU OUCRU-HCMC to ensure optimal communications between OUCRU and these bodies.
• Support the preparation and presentation of applications to ethical committees and regulators
• Understand the study protocols, assist in recruitment of patients to studies if required
• Co-ordinate, oversee and at times assist in the collection of clinical data and research samples from participants (inpatients, outpatients, participants at community sites)
• Ensure that clinical case report forms are completed accurately by collaborating staff
• Ensure data entry into electronic databases, data cleaning and validation is timely and accurate
• Develop monitoring plans, if necessary with support from CTU OUCRU-HCMC
• Implement or oversee the implementation of monitoring plans based on study progress
• Involvement in organizing DSMB meetings and other interim reports on studies in collaboration with the study PIs
• Maintain good communication with collaborating staff at study sites, to ensure participants' wellbeing, compliance with study protocols and quality of clinical data.
• Assist with presenting study progress and findings to collaborators and other audiences
• Assist in organizing events related to research, ethics and trials governance as required
• Build a good relationship with study sites and act as a liaison between OUCRU-VN and the site
• Work with other members of the project team to identify areas for collaboration and research.
• Other tasks as required
Essential Criteria:
• Medical doctor or Masters degree in a health related science
• Excellent Vietnamese and English language skills
• Clinical Research Experience
• Good understanding of how to apply Good Clinical Practice guidelines in clinical research
• Excellent skills in oral and written communication, coordination and project management
• Ability to work closely with other study staff, hospital and public health/government collaborators
• Good attention to detail in following protocols and keeping records
• Interest in clinical and/or epidemiological research
• Willing to travel within country and abroad
Desirable Criteria:
• Experience in working in an international environment
• Experience in clinical trials
• Experience managing teams
• Experience in liaising with Ministries and/or other national bodies
• Understanding of academic, research or not-for-profit working environment
• Able to work with a minimum of supervision
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
Deadline for submission 29 March 2019

Quyền lợi

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Thông tin chung

  • Ngày hết hạn: 21/04/2019
  • Thu nhập: Thỏa thuận
Giới thiệu công ty Xem trang công ty
Our ten-year vision is to have local, regional and global impact on health by leading aOur 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. locally driven research programme on infectious diseases in Southeast Asia.
Quy mô công ty
Từ 101 - 500 nhân viên

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Oxford University Clinical Research Unit
Địa chỉ công ty: Địa điểm: 764 Vo Van Kiet Ward 1 District 5

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