Trial Officer

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

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 80 full-time staff and coordinates multiple study projects within lung health management and treatment, antimicrobial resistance across eleven provinces. We are rapidly expanding our activities in southern region, particularly Ho Chi Minh City, and looking for research enthusiasts to join our young and professional team.

For more information about us, please visit:

Woolcock Institute of Medical Research in Sydney, Australia: www.woolcock.org.au
Woolcock Institute of Medical Research in Vietnam: www.woolcockvietnam.org

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 as follows: http://bit.ly/woolcockhiring

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.