Research Pharmacy Coordinator (JD-0619-013)

 

Position

Research Pharmacy Coordinator

Department 

Clinical Trial Unit (CTU)

Location

This post is based in Ho Chi Minh City, Viet Nam. Travel to hospitals or units around Ho Chi Minh City will be required regularly. Travel within V or internationally will be required.

Hours of work

Full-time 

Tenure

This is a 1 year
contract position with possibility of extension

Reporting to 

Pharmacy Team Leader

Vacancy reference 

JD-0619-013

Background

The Oxford University Clinical Research Unit (OUCRU) is a large-scale clinical and public health research unit based in Viet Nam. We are hosted by the Hospital of Tropical Diseases (HTD) in Ho Chi Minh City, and the National Hospital for Tropical Diseases (NHTD) in Hanoi. We also have sister units in Kathmandu, Jakarta and Shantou.  As a Wellcome Trust Major Overseas Programme, we have received considerable support from the Wellcome Trust since our establishment in 1991.

OUCRU aims to have a positive and significant impact on global health and, in particular, the prevention, diagnosis and treatment of infectious diseases. This is being achieved via an integrated long-term research programme, contributions to training, the scientific literature, national and international meetings and membership of national and international committees. Priority is given to health issues important to the hospitals, and to Viet Nam as a whole. All work is intended not only to benefit the patients seen daily at our host hospitals, but also to help improve patient care throughout Viet Nam and the region.

Please see more information on OUCRU Website: www.oucru.org.

Job summary

The Research Pharmacy coordinator is responsible for managing all investigational products used in OUCRU-VN clinical research. The Research Pharmacy coordinator will 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. The Research Pharmacy coordinator will oversee satellite clinical research pharmacies and be responsible to train pharmacy and study staff in procedures of maintaining a clinical research pharmacy.

Key responsibilities and tasks

The post-holder will be based within the OUCRU-VN Clinical Trials Unit and have key tasks and responsibilities below:

 

Key duties/tasks:     

  • 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.
  • Manage the OUCRU 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.
  • Support Pharmacy Team Leader to develop OUCRU Pharmacy 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 Unit. Ensure that all pharmacy procedures comply with relevant guidelines and regulations.
  • Build capacity and scope of the OUCRU pharmaceutical network and 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.
  • Support Pharmacy Team Leader to research and source suppliers of drugs and formulations to be used in clinical trials.  Process the regulatory permissions necessary to import and use new products.
  • Support Pharmacy Team Leader to assemble the documentation necessary for the Viet Nam Ministry of Health review of clinical trials and the Drug Administration Board import permits of unlicensed products for use in clinical trials.
  • Support the Pharmacy Team Leader in collaboration with statisticians to design 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.
  • 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.
  • Be available outside of working hours in urgent cases to verify the prescription of study patients.
  • Other tasks as required.

Selection criteria

Essential:

  • Degree in Pharmacist Diploma
  • 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

 

Desirable Criteria:

  • Experience in clinical research
  • Knowledge of GMP (Good Manufacturing Practices ), GSP (Good Storage Practice), GPP (Good Pharmacy Practices) and ICH-GCP International Council for Harmonisation Good clinical practice)

Benefits 

  • Contracted salary: Negotiate (depending on actual experience and education).
  • Optional insurance: In-patient and out-patient medical coverage; Personal accident insurance coverage
  • Two-month salary for annual bonus and clothes
  • Annual leave 18 days/year for the first year, a maximum of 30 days.
  • Other responsibilities and benefits are based on Viet Nam Labor Law. 

How to apply 

Interested qualified candidates are invited to send their detailed resume and cover letter in English, including copies of relevant degrees, certificates, either by email or by post to the following address:

Oxford University Clinical Research Unit

Laboratory of Clinical Science

Hospital for Tropical Diseases

764 Vo Van Kiet, Ward 1, District 5, HCMC

Tel: 39237954

Email: hr@oucru.org

 

* We thanks all applicants, but only short-listed candidates will be contacted for interview.

Contact person 

Ms. Nguyen Thi Hong Phuc 

Deadline for submission 

25th June 2019