Trial Officer

The Woolcock Institute is lung health research organisation, based at Sydney University, Australia (http://www.woolcock.org.au/). The Institute has operated in Vietnam since 2009, we undertake large and important operational and epidemiological and clinical research projects in collaboration with the National Tuberculosis Program in 9 Provinces, including Hanoi and Ho Chi Minh City. The Woolcock also runs training in epidemiological and operational research methods for Vietnamese doctors and public health workers.

Currently the Woolcock directly employs 50 full-time staff in Hanoi, Ho Chi Minh City and Ca Mau. We are substantially expanding our organization, as we prepare for the implementation of a major new clinical trial in 2015. We are recruiting a highly motivated and experienced Trial manager to run this new study, which will be conducted in 10 Provinces.

Location: 01 position based in Da Nang

Duration: 01 year appointment, with consideration for subsequent extension

Role:

• To take a leading role in establishing, executing and monitoring of the VQUIN and ACT4 studies
• Ensure in keeping with international standards of Good Clinical Practice
• Building a team of enthusiastic and capable research staff in 10 Provinces of Vietnam.

Report to: Trial Coordinators, 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
  • 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

• 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 Coordinators and Chief Investigators
  • Participating to regular meeting with Trial Coordinators and Chief Investigators

• Logistical support
  
  • Organize 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.
  • Reporting all required report on time
  • Planning and supporting the local partners in onganisation related workshops or seminars.
  • 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

• Qualifications
  
  • University degree in Medicine, Nursing, Pharmacy, Science, Public Health or related field.

• Essential criteria
  
  • Experience in implementation of research or 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

• Desirable criteria
  
  • Current Good Clinical Practice certificate
  • Good English language skills
  • Experience in blood taking

Interested applicants should send an application letter together with a CV in English to the following address with the subject title “Trial Officer Application”, no later than 20th April 2017.

The detailed Job Description is available upon request. Only short-listed candidates will be contacted for interviews. The application will not be returned. Electronic application is acceptable.

Applications should include:

(a) a cover letter
(b) a detailed Curriculum Vitae
(c) the names and contact details of least three senior referees

Send applications by mail to: Dr. Nguyen Cam Binh
Add: Room No.12.05, B2 Block, Giai Viet building, 340 Ta Quang Buu Street, Ward 5, District 8, Ho Chi
Minh city, Viet Nam.
Phone: (+88)62515783/84
Email: [email protected] cc to [email protected] and [email protected]