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About FHI 360:

FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research and technology — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 70 countries and all U.S. states and territories. We are currently seeking qualified candidates for the position of: Document Controller in Bangkok, Thailand.

Job Summary / Responsibilities:

Works closely with research-related staff to support research activities by providing the day-to-day implementation, management, tracking and support of research-related document management and study-specific filing activities. Specifically, the key responsibilities are:

• Responsible for the completeness and compliance of the Trial Master Files and all APRO-led clinical research studies and associated tracking databases and ensure that all study documents are entered in an accurate and timely fashion.

• Responsible for receiving, checking and filing research documents received for the study TMFs under FHI 360 control.

• Ensure compliance of assigned functions and responsibilities in compliance with study-specific and FHI 360 procedures, Standard Operating Procedures (SOPs), FHI 360 Policies and Procedures, and Good Clinical Practice’s (GCP).

• Review documents received for filing and advise study team members of any errors, omissions or incomplete document submissions.

• Provide technical assistance to research staff, in-country/region colleagues, and other staff (FHI 360 and external) as needed relating to document management, procedure development, filing, and tracking system.

• Perform and report periodic internal quality checks on the completeness and compliance of study files; follow-up with study teams as needed.

• Manage the FHI 360 Document Control Room in Bangkok including monitoring for temperature, humidity, security and access.

• Develop and maintain written procedures for use, management and control of the FHI 360 TMF and document control room.

• Generate routine reports of study file status and assist the APRO research team with administrative research-related functions as needed and assigned.

Qualifications:

•  BS/BA in business administration, public health or related field.

•  At least 5 years relevant experience and professional level of knowledge with at least 2 years executive secretarial of administrative management experience.

• Excellent general office ,administrative and organizational skills with high attention to detail.

• Experience with managing high volume work flow with minimal supervision

• Proven Experience with managing filing systems and electronic tracking databases or equivalent.

• Resourceful in gathering and providing information and proposing solutions to issues.

• Good in both written and spoken English.

• Fully competent in computer software use skills including Microsoft Word, Excel, PowerPoint, and Access.

This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

We offer competitive compensation and an outstanding benefit package.Interested candidates, please register online through FHI 360’s Career Center at https://jobs-fhi360.icims.com/jobs

FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is committed to providing equal employment opportunity without regard to race, color, religion, sex, gender identity, sexual orientation, national or ethnic origin, age, disability or status as a veteran with respect to policies, programs, or activities.