FHI 360 is an international non-governmental organization that works with the Vietnam Ministry of Health, other ministries, provincial health services, and local non-government organizations to promote the health and well-being of the Vietnamese population, particularly vulnerable and disenfranchised groups. FHI 360 is currently building the capacity of local organizations in HIV/AIDS prevention, care, and treatment; clinical research for the development of vaccines and drugs for infectious diseases; tobacco control; and laboratory strengthening.
We are currently seeking qualified and highly motivated Vietnamese national to fill the vacancy of Senior Technical Officer, Clinical Research to work in our Hochiminh City office.
Position Summary:
The incumbent will work within the assigned study requirements to oversee and assist the study site to ensure that the study is conducted properly and meets all applicable requirements including compliance with Good Clinical Practice (GCP).
Main duties and responsibilities:
- Work closely with other research staff to conduct clinical research activities (e.g., site training, protocol development, study-specific procedure development, project management, study implementation, data analysis, data monitoring, data management, clinical monitoring, paper/report writing).
- Monitor the qualitative and quantitative progress of research and research implementation activities.
- Participate in selecting, developing and building the capacity of country project sites.
- Help with tracking site opening progress
- Follow up and review the site’s conduct of the study, identify areas where re-training is needed to ensure protocol compliance and conduct re-training as needed.
- Review study documents for completeness and accuracy
- Oversee the collection of pharmacovigilance data by study sites
- Perform drug accountability at the investigative site.
- Perform source data verification of CRFs versus source documentation as required by the study protocol and monitoring plan.
- Review compliance with site reporting requirements to FHI360, the IRB/IEC, local regulatory agencies, and sponsor;
- Prepare and provide trainings to study sites and investigational teams on the study protocol, study specific procedures, Good Clinical Practice (GCP), and research ethics.
- Monitor site staff’s work and provide assistance to other CRAs, colleagues, and others as needed.
The successful candidate will have the following qualifications and abilities:
- Medical doctor (M.D) or Bachelor in public health, pharmacy or nursing; preferably a Master’s degree in public health, clinical epidemiology or health related field;
- Two years relevant work experience and professional knowledge and expertise in GCPs and research implementation;
- Knowledge of and ability to use electronic data processing systems to gather, store, retrieve and analyze data.
- Strong interpersonal skill and ability to work both in teams and independently with minimal supervision.
- English proficiency and computer literacy (MS Office, email, Internet Explorer..)
- Ability to travel both in-country and internationally as needed.
FHI 360 offers a competitive salary and excellent benefits.
Please send detailed curriculum vitae with letter of application and copies of degrees and certificates in English by October 10, 2013 to:
Human Resources Section, FHI 360 Vietnam
7 Floor, Hanoi Tourist Building, No. 18 Ly Thuong Kiet, Hoan Kiem Hanoi, Vietnam
Email: [email protected] [1]
Please specify the position you are applying for in your application.
Only shortlisted candidates will be contacted for interviews.