Clinical Research Associate

FHI 360 is an international, non-governmental organization that works with the Vietnam Ministry of Health, provincial health services, and local non-government organizations to promote the health and well-being of the Vietnamese people, particularly vulnerable and marginalized populations. In Vietnam, FHI 360 is currently building the capacity of local organizations in HIV prevention, care & treatment; drug treatment policy & practice; clinical research for the development of vaccines and drugs; and maternal and child health and nutrition.

We are currently seeking a qualified, experienced, and highly motivated candidate for the position of Clinical Research Associate, based in Hochiminh City:

Job Summary/Responsibilities:

The Clinical Research Associate (CRA) monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols.

• Reviews regulatory documents as required and prepares site visit reports. May be responsible for multiple projects and must work both independently and in a team environment.
• Participates in the study development and start-up process including reviewing protocols, designing and/or reviewing Case Report Forms (CRF), preparing Informed Consent Forms (ICF’s), developing study documents, organizing and presenting at investigator meetings, working with management on a monitoring strategy, and/or developing project-specific CRA training.
• Participates in clinical training programs and maintain awareness of developments in the field of clinical research as needed. S/he may provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Prepares clinical documents, business correspondence, and procedural manuals.
• Maintains systems and process necessary to report trial status and activities; and to help ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget.
• Depending upon the level of experience, may become involved, when required, in other areas of study management and staff training and contributes to the review of sponsor/client’s and/or FHI 360’s systems and procedures as appropriate.

Qualifications and experience for the position:

• Master’s degree or its international equivalent preferred
• Related prior work experience
• Working knowledge of concepts, practices and procedures for conducting clinical research studies
• Proficiency in Microsoft Office, spreadsheet software and other technology required
• Articulate, professional and able to communicate in a clear, positive fashion with clients and staff
• Must be able to read, write and speak fluent English

FHI 360 offers a competitive salary and outstanding benefit package

Please send detailed curriculum vitae with letter of application in English by September 30, 2016 to:

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

Please specify the position you are applying for in your application.

Only shortlisted candidates will be contacted for interviews.