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: 2 positions based in Ho Chi Minh City

Role:

• To take a leading role in establishing, executing and monitoring the trial
• 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 structures/relationships: Trial Manager

Main 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

• 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 / Selection criteria:

Key attributes

• Ability to work within a team and organise it
• Management skills
• Strategic planning
• Ability to prioritise
• A motivator with good listening skills
• Focused, but flexible approach
• Willingness to work hard
• Knowledge/experience of all relevant guidance/regulations
• Ability to pay close attention to detail

Qualifications

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

Essential criteria

• 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

Desirable criteria

• Current Good Clinical Practice certificate
• Good English language skills

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 June 15th, 2015.

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.4.05, 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] and cc to [email protected]