The Woolcock Institute is lung health research organisation, based at Sydney University, Australia (http://www.woolcock.org.au/ [1]). 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 Ho Chi Minh City
Role:
To lead the implementation of VQUIN in 5 Provinces of Vietnam in the South area including: Khanh Hoa, Ho Chi Minh City, Tien Giang, An Giang, Can Tho. The role includes:
- Taking a leading role in planning, executing, monitoring and controlling the trial
- Overseeing quality assurance and safety for the clinical trial, in keeping with international standards of Good Clinical Practice
- Building a team of enthusiastic and capable research staff in 5 Provinces delegated
Report structures/relationships: VQUIN Trial Coordinator
Direct line supervisor for: all Trial Officers in delegated study areas
Main duties and Responsibilities:
- Develop and strengthen key relationships with collaborative partners in assigned areas
- Planning and executing the trial
- Implementing pilot projects to test key components of the trial
- Assembling and training a team to oversee the trial
- Assisting in the evaluation of trial-related materials including the Standard Operating
- Procedures, trial documentation and forms, and trial marketing (promotion) materials
- Overseeing preparation and submission of routine regulatory and ethical review submissions and reports within delegated authority and areas
- Maintaining facilities and equipment as required for implementing the trial (including drug procurement)
- Training field research teams and government health staff to implement the SOPs (including informed consent, safety and compliance issues)
- Being the primary point of contact between Woolcock, the investigators, and the research sites in delegated Provinces for the implementation of the research
- Co-ordination and monitoring of the clinical trial
- Monitoring of the implementation of the trial including subject recruitment and implementation of all study procedures
- Data collection and management
- Monitoring data quality
- Collection and archiving of source documents
- Assisting in report of adverse events
- Managing monitoring visits and dealing with queries
- Preparing reports for the Trial Coordinator on progress of trial implementation
- Communication with Trial Coordinator, Country Director, WIMR management, and the Chief Investigators
- Coordination of visits by Chief Investigators and Trial Coordinator
- Preparing project progress reports to Trial Coordinator and other partners when required
- Financial accountability
- Fulfilling financial responsibilities delegated according to VQUIN financial procedures
- Establishing effective procurement control and asset management in delegated study areas
- Assisting in oversight of budget, audit and financial accounting in delegated study areas
- Ensure efficient expenditure of resources
- Ensuring appropriate financial control processes are followed
- Human resource management accountability
- Assist in recruiting local staff to conduct the research in delegated study areas
- Supervise performance of all staff under delegated authority
- Foster a community of learning and teamwork, continuous quality improvement and continuous professional development for staff
- Close-out of the trial
- Assisting in communication with organisations involved within delegated study areas
- Assisting in preparation of the final study report
- Notifying Trial Coordinator, Country Director and Chief Investigators about problems arising in the study
- Foster a community of learning and teamwork, continuous quality improvement and continuous professional development for staff
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 “Southern Area Leader Application”, no later than September 30th, 2016. 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] [2] cc to [email protected] [3] and [email protected] [4]