Clinical Research Associate

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 Clinical Research Associate for our Hochiminh City office.
Position Summary:
The incumbent will work within assigned study site to oversee and assist the 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:
- Track site opening progress (IRB approvals, completion) and assist in completing site opening tasks.
- During study, follow-up, review the site’s conduct of the study, identify areas where re-training is needed to ensure protocol compliance, and re-train as needed.
- Review study documents for completeness and accuracy, including informed consent forms, study CRF’s, site regulatory documents, study logs and other study documentation.
- Perform drug accountability in conjunction with the FHI360, site pharmacist, and source data verification of CRFs versus source documentation.
- Review and ensure compliance with site reporting requirements to FHI360, the IRB/IEC and local regulatory agencies; compliance of the study at the site with the protocol, GCP, FDA, local country regulations and study-specific SOPs.
- Work closely and provide support to study staff, other CRAs, in-country colleagues, and others.
- Prepare and track budgets and other necessary documents when required.
- Represent FHI360 at study sites and meetings as needed.
- Perform other related duties as assigned.
The successful candidate will have the following qualifications and abilities:
- BS/BA with experience in clinical research, preferably with malaria or other infectious diseases
- Minimum of 1 year of on-site clinical monitoring experience. Experience with NGOs/INGOs is preferable.
- Knowledge of and ability to use electronic data processing systems to gather, store, retrieve and analyze data.
- Good management skills and ability to monitor projects, set up priorities and plan for successful program implementation
- Strong interpersonal skill and ability to work both in teams and independently with minimal supervision.
- Excellent written, verbal English language skills
- Experience using MS Office, email, Internet Explorer
- Ability to travel up to 50%
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 December 25, 2012 to:
Human Resources Section, FHI 360 Vietnam
7th Floor, Hanoi Tourist Building, No. 18 Ly Thuong Kiet, Hoan Kiem Hanoi, Vietnam
Email: [email protected]

Job Details
Organisation Name: 
FHI 360
Application Deadline: 
Tue, 2012-12-25