Clinical Research Associate II & III

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 for qualified and highly motivated Vietnamese nationals to involve in our proposal for a study project. The vacant proposal positions to be filled are Clinical Research Associate II and Clinical Research Associate III.

Summary of responsibilites:

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

S/he will prepare clinical documents, business correspondence, and procedural manuals. Maintain 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.

Requirements for qualifications and experience:

1) Clinical Research Associate II position (based in Hanoi)

• Bachelor’s degree or its international equivalent in Health, Behavioral, Life or Social Sciences or other fields related to international/ human development with at least 3 years of previous clinical research experience
• Master’s degree or its international equivalent preferred

2) Clinical Research Associate III position (based in either Hanoi or Hochiminh City)

• Bachelor’s degree or its international equivalent in clinical, science, or health related field with at least 6+ years of clinical research experience including assisting with protocol development, clinical monitoring, study implementation, study close out, project management, analysis and reporting
• ACRP or SoCRA certification required
• Project or technical leadership experience required.
• Advanced degree or its international equivalent preferred.
• Supervisory or management experience preferred.
• Global clinical research work preferred.

The successful candidates for both positions will have the following knowledge and abilities:

• 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 August 23, 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.