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 wellbeing 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 I to work in our Hanoi office.

Position Summary:

The incumbent will monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols. S/he will participate 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.

Major duties and responsibilities:

• Assists in the preparation of routine protocols, informed consents, SOPs, and other appropriate documentation
• Monitors clinical trials to ensure subject safety and compliance with the study protocol, FDA regulations and ICH/GCP Guidelines
• Coordinates necessary activities required to set-up, monitor, and close-out clinical trials sites
• Conduct site assessment, initiation, routine, and close-out monitoring visits, may require supervision.
• Complete accurate monitoring visit reports.
• Develops training materials and conducts training for study implementation based on company policies and SOPs.

The successful candidate will have the following qualifications and abilities:

• Bachelor’s degree or its international equivalent in clinical, science, or health related field with at least 3 years of previous clinical research experience.
• Working knowledge of concepts, practices and procedures for conducting clinical research studies.
• Solid knowledge of software programs used to collect data and track risk based monitoring parameters.
• Ability to analyze and interpret data, identify errors and prepare reports.
• Exceptional attention to detail.
• Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.
• Able to read, write and speak fluent English.
• Proficient in Microsoft Office, spreadsheet software and other technology required.
• Ability to travel 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 June 10, 2015 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.