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: Ho Chi Minh City, with frequent travel to other provinces to perform monitoring
Role:
- Responsible for managing all investigational products used for the V-QUIN trial.
- Manage the supply chain for all consumables and equipment required for the V-QUIN MDR trial, throughout participating provinces
- Perform duties associated with dispensing and control of investigational products and ensure that standard operating procedures are in place to control the quality of pharmaceutical practice for studies in Viet Nam’s most significant infectious diseases.
- Perform field visits to supervise the appropriate distribution and storage of investigational product and other equipment required for the study.
- Train study staff in procedures of maintaining a clinical research pharmacy.
Report structures/relationships: Trial Manager
Main duties and Responsibilities:
Management of investigational product
- Safeguard research participants, patients and researchers by ensuring that investigational medicinal products are appropriate for use and are procured, handled stored and used safely and correctly in accordance with the study protocol.
- Develop and manage the Woolcock Clinical Research Pharmacy including a fully documented medicine management system.
- Control, label, dispense and maintain records for investigational medicinal products and create procedures to standardize these actions. Manage the health and safety aspects of drug handling, dispensing and reconstitution.
- Develop standard operating procedures to determine how investigational medicinal products are controlled, dispensed, blinded, unblinded, reported and destroyed. Work with Study Coordinator/Manager to develop study specific standard operating procedures.
- Plan and prepare patient treatment kits. Manage logistics and documentation from suppliers and external sites.
- Establish a resource of standard documents, policies, operating procedures and record keeping for a network of pharmacies. Monitor pharmaceutical practice in a network of clinical trials pharmacies.
- Contribute to the ongoing development and control of general and study specific standard operating procedures to determine how investigational medicinal products are controlled, dispensed, blinded, unblinded, reported and destroyed.
- Maintain an up-to-date understanding of local and international pharmaceutical and clinical trial regulations. Communicate information and updates to staff at the Institution. Ensure that all pharmacy procedures comply with relevant guidelines and regulations.
- Work towards the standards of Good Pharmaceutical Practice and/or Good Storage Practice. Develop and implement quality assurance and quality control tools for these pharmacies.
- Process the regulatory permissions necessary to import and use new products.
- Work with the Principal Investigator to implement randomization sequences, tracking processes and tools to meet the design requirements of the study protocol.
- Source and purchase medicines as required for studies. Arrange for transfer and shipping as required, under appropriate storage conditions
- Ensure that all data and documentation associated with a study are accurate, up-to-date and available for audit or inspection by an appropriate authority.
Supply chain
- Organize the purchase of study equipment and consumables for the study
- Develop and maintain inventories for all study equipments within provinces participating in the study
- Travel to participating provinces to perform monitoring vistis of inventory and supply of all equipment and investigational products.
Other roles
- Be available outside of working hours in urgent cases to verify the prescription of study patients.
- Other administrative tasks as required.
Key attributes / Selection criteria:
- Methodical approach to record-keeping
- Pro-active approach to self-learning and implementation of new systems
- Familiarity with computers, particularly MS Office: Word, Excel, PowerPoint, and e mail
- Good written and spoken English and Vietnamese
- Training in pharmaceuticals
- Pharmacy Diploma
- Experience in clinical research
- Knowledge of Good Pharmaceutical Practice and Good Clinical Practice
Interested applicants should send an application letter together with a CV in English to the following address with the subject title “Supply Chain and Pharmacy Coordinator Application”, no later than May 31st, 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] [2] and cc to [email protected] [3]