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 to work in our Hochiminh City office.

Position Summary:

The incumbent will work within the assigned study site 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:

• Track site opening progress (IRB approvals, completion) and assist site with 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 and site pharmacist.
• Perform source data verification of CRFs versus source documentation.
• Review compliance with site reporting requirements to FHI360, the IRB/IEC and local regulatory agencies; assist with any issues identified and communicate issues to FHI360.
• Review work done at sites and provide education and training to site staff as needed.
• Ensure compliance of the study at the sire with the protocol, GCP, FDA and local country regulations and study-specific SOPs.
• Monitor the completeness and accuracy of study staff’s work.
• Work closely with study staff, focusing on protocol compliance and site development.
• Provide support to site staff as needed.
• Prepare and track budgets and other necessary documents when required, working in conjunction with FHI360 staff.
• Provide assistance to other CRAs, in-country colleagues, and others as needed.
• Attend meetings and trainings as required.
• Report site progress to study team as 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
• Ability to travel up to 50%
• 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...)

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 5 pm July 12, 2014 to:

Human Resources Section, FHI 360 Vietnam
7 Floor, Hanoi Tourist Building, No. 18 Ly Thuong Kiet, Hoan Kiem Hanoi, Vietnam
Email: [email protected]