[HCM] Viện Nghiên Cứu The Woolcock Institute Of Medical Research In Vietnam Tuyển Trial Officer Full-time 2023

Job description - Trial Officer
Job code: 08062301
Job category: Clinical Trials
Job level: Officer
Type of work: Fulltime
Duration: until 31/12/2023 with possibility of extension
Location: Hanoi, may require domestic travel to research sites
Regional office: Ha Noi
Direct report: Study Manager
Dotted-line reporting:
Tentative start date: As soon as in June 2023
Organisation: Woolcock Institute of Medical Research
Role:
To assist, implement and monitor assigned clinical trials;
To ensure the compliance with Good Clinical Practice standards.
Key staff working with:
Project 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;
Supporting 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:
Organise logistics of study materials including drugs, files, test kits, patient samples, data and other materials.
- Data collection and administration:
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.
Selection criteria:
University degree in Medicine, Nursing, Pharmacy, Science, Public Health or related field
Key attributes:
Experience in blood taking or laboratory (preferred)
Experience in implementation of clinical trials in Vietnam
Ability to work as a member of a team, and collaborate closely with government health staff
High level of organizational and record keeping skills.
Knowledge of ICH GCP guidelines.
An ability to work independently
Ability to communicate fluently in Vietnamese and English
Applications:
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 30/06/2023 by submitting the application form IN THE LINK
We regret that only short-listed candidates will be contacted for interviews. Review of applications will start as soon as possible and continue until 30/06/2023, or until the post is filled, whichever is earlier.