Clinical Research Manager

Background

Oxford University has two Clinical Research Units in Viet Nam working in partnership with the Hospital for Tropical Diseases in Ho Chi Minh City,  the National Hospital for Tropical Diseases in Hanoi, a network of hospitals across Viet Nam and Asia to conduct a wide range of clinical studies including clinical trials of drugs and vaccines.

The Unit’s main focus of work is in Dengue, Infections of the Central Nervous System, Respiratory Infections, Antibiotic Resistance, Influenza, HIV and Tuberculosis.

Research operations are managed by the Clinical Trials Unit which has seen considerable growth in the past 2 years to accommodate for increasing number of trials.  OUCRU-VN has recently been awarded grant funding from international donors to implement observational studies in Dengue fever and a randomized controlled trial in the treatment of opportunistic infections in HIV.

Job summary

The recent, impressive growth in clinical trials capacity and opportunity needs to be matched with trained and qualified clinical trials staff to ensure efficient and high quality research operations in line with international standards

The post of Clinical Research Manager is required to meet the challenge of this expansion, to execute new research projects recently funded including randomized controlled trials across Asia to manage the implementation of trials and to support and develop the current activities of the Clinical Trials Unit.

The post-holder will also play a key role in data management and development of staff responsible for coordinating and monitoring OUCRU studies. 

He/she should be pro-active and ensure the work is of high standard.

Working place:

Oxford University Clinical Research Unit in Hanoi,
6th Floor, National Hospital for Tropical Diseases,
Bach Mai Hospital, 78 Giai Phong, Dong Da, Hanoi.

Travel within Viet Nam or internationally will be required.

Responsible to: Dr.  Heiman Wertheim – Director of Hanoi Unit

Tenure: Contract for one year on completion of 2 months probation with possibility of extension.

Hours of work: Full time; 37.5 hours/week – Monday to Friday

Benefit

- Contracted salary:  Negotiate (depending on actual experience and education)
- Health insurance through AonCare: 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

Key responsibilities and tasks

- Help in protocol and CRF development and implementation and ensure correct Vietnamese translations.
- Support the preparation and presentation of applications to ethical committees and regulators
- Develop standard operating procedures and logistical plans for the implementation of a clinical trial
- Understand the study protocol, recruit patients to clinical studies
- Communicate with study participants about their illness, clinical management, and the clinical research studies, and provide advice about seeking healthcare at study sites or non-study sites as appropriate.
- Collect, co-ordinate and oversee 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 hospital staff.
- Ensure data entry into the electronic databases, data cleaning and validation, and subsequently with data analysis
- Implement the monitoring plan by arranging visits with the study site based on study progress.  
- Maintain good communication with research nurses and collaborating hospital staff at each site, 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.
- 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.
- Supervise a team of clinical trial specialists
- Other tasks as required.

Qualifications

Essential Criteria:

- Medical degree
- Excellent Vietnamese and English language skills
- 2 years experience in a Vietnamese government hospital
- Clinical Research Experience and preferably a Master degree or at least level 1 subspecialty training
- Good understanding of how to apply Good Clinical Practice guidelines in clinical research
- Excellent skills in communication and patient care
- Ability to work closely with other study staff and hospital 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
- Prior experience in clinical research, particularly in HIV area
- Familiarity with computers, including Word and database programs
- 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
Bui Huyen Trang
Oxford University Clinical Research Unit Vietnam
6th Floor, National Hospital for Tropical Diseases
Bach Mai Hospital
78 Giai phong, Dong da, Ha noi
Email: [email protected]
Website: www.oucru.org

* 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 applicants will be contacted for interview. Please no telephone contact after submitting the application

Deadline for submission: 1 November 2012

Job Details
Organisation Name: 
OUCRU-VN
Location: 
Ha Noi
Application Deadline: 
Thu, 2012-11-01