Job description – Trial Officer – Clinical trials
Organisation: Woolcock Institute of Medical Research
The Woolcock Institute of Medical Research is affiliated with the University of Sydney in Australia and is recognized as one of the leading research institutions for respiratory diseases and sleep disorders. Operating in Vietnam since 2009, we have undertaken large operational, epidemiological and clinical research projects and run training in epidemiological and operational research methods for Vietnamese doctors and public health workers. The Woolcock Institute has three research centres and offices in Ha Noi, Ho Chi Minh City and Ca Mau. Currently we directly employ about 50 full-time staff and coordinates multiple study projects within lung health management and treatment across eleven provinces. We also expand research activity to other fields including antimicrobial resistance.
For more information about us, please visit:
Woolcock Institute of Medical Research in Sydney, Australia: http://www.woolcock.org.au/ [1]
Woolcock Institute of Medical Research in Vietnam: http://www.woolcockvietnam.org/ [2]
Location: Hanoi with possibility of domestic travel
Duration: 12 months appointment, with consideration for subsequent extension. This position will be on full time basis.
Direct report:
Trial Coordinator/Area Leader, Woolcock Institute of Medical Research
Key staff working with the project:
- Trial Officers
- Local health workers
- Local financial controller
- Technical managers (such as Laboratory staff)
Duties and Responsibilities
Trial recruitment and case-management:
- Recruiting study subjects (including patients with TB and their household contacts)
- Scheduling appointments for the follow-up of study subjects
- Conducting assessments of study subjects during routine follow-up visits
- Referring subjects for medical assessment according to protocols
- Arranging routine diagnostic testing of subjects
- Support local health care workers in recruitment, clinical assessment and reporting (including Provincial Hospital and District Clinic staff)
Training and oversight:
- Providing support for training of local health staff
- Organise and facilitate training workshops within the Province
- Understand relevant clinical research protocols and regulatory requirements.
- Train local partners in protocol relevant procedures including those for laboratory samples, data collection and recording, medication and patient assessment
Team collaboration:
- Working closely with the Trial Coordinator and Chief Investigators
- Notifying Country Director and Chief Investigators about problems arising in the study
Logistical support:
- Organize logistics of study materials including drugs, files, test kits, patient samples, data and other materials
Data collection and administration:
- Support in designing data platform and data management
- Plan, implement and coordinate all aspects of data collection, recording and source documentation, as per hospital and Woolcock 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.
- Verify that data entered on to CRFs is complete and consistent with patient clinical notes, known as source data/document verification.
- Coordinate patient visit schedules as per study protocol.
Good clinical practice compliance:
- 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.
- Track study progress and identify problems. Report to stakeholders as required.
- Support study monitoring
- Liaise with sponsor for monitoring/audits. Write, file and collate trial documentation and visit reports with respect to monitoring.
- Participate in study team meetings to share experience and contribute to the knowledge of others in the team.
Other tasks:
- Attend career training to improve skills and update relevant knowledge.
- Other tasks as required
Key attributes:
- Experience in implementation of clinical trials in Vietnam
- Strong diplomatic skills.
- Ability to work as a member of a team, and collaborate closely with government health staff
- Ability to conduct a basic clinical assessment
- Proven oral and written presentation skills.
- Excellent communication and interpersonal skills.
- High level of organizational and record keeping skills.
- Knowledge of ICH GCP guidelines.
- An ability to work independently
- Ability to communicate fluently in Vietnamese
- Current Good Clinical Practice certificate
- Good English language skills
Application Procedure
For interested applicants, please send a cover letter together with a CV (with the name and contact details of at least three senior referees) in English or Vietnamese and scanned copies of your related degrees, no later than 31/05/2022 by submitting the application form in the link as follows:
https://airtable.com/shrEHhrmyayGTWOjs [3]
We regret that only short-listed candidates will be contacted for interviews.
Review of applications will start as soon as possible and continue until 31/05/2022, or until the post is filled, whichever is earlier.