Staff within the Science Facilitation Department of FHI 360 serve as the Operation Center for the US National Institutes of Health (NIH)-sponsored International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network. The Operations Center is responsible for contributing to and supporting the development, implementation and reporting of all IMPAACT clinical trials and for providing a central point of coordination, communications, and support to the IMPAACT Leadership Group and all network committees, protocol teams, and working groups. The Operations Center is also responsible for arranging and supporting all network meetings; for the governance of the network and communications; and for providing logistical and administrative support for the IMPAACT leadership and other committees.
Operations Center staff work closely with the IMPAACT leadership, staff from the Statistical and Data Management Center (SDMC), Laboratory Center (LC), Clinical Research Sites (CRSs), Division of AIDS (DAIDS) within NIAID, network committees, study teams, clinical research sites and their community programs on all aspects of the IMPAACT scientific research agenda.
The Clinical Trial Associate (CTA) is a member of the IMPAACT Operations Center and assists the team in the implementation of clinical trials. Responsible for the collection, review, tracking, maintenance and archiving of essential study documents in the Trial Master File (TMF), ensuring that project-specific administrative documents (e.g., contact lists, etc.) are maintained, and ensures sites are supplied with all required materials and supplies. Frequent contact with internal and investigator site personnel. May be responsible for managing individual, large, or complex studies / programs. Assists the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support. Key role in supporting project team needs.
- Supports clinical teams by performing tasks related to study management from start up to study completion.
- Provides administrative support to the project team.
- Assists the clinical project management team with written and verbal communications with study staff and sites.
- Assists the clinical project management team with the creation of study-specific documents and materials, and with the acquisition of study supplies.
- Utilizes technology effectively to support clinical development processes; develops mastery of relevant systems (e.g. study management tools) and identifies new innovative ideas and shares best practices.
- Prepares and issues meeting minutes, including action items, under the direction of project management.
- Maintains the study-specific TMF and associated electronic archives.
- Assists the clinical project management team with the organization of meetings.
- Support the clinical operations teams with ongoing conduct of studies.
- Assists in the close-out of projects by performing a final Quality Control (QC) of the TMF, identifying items and issues for review and/or follow-up by the CRAs and/or project management.
- Assist in the production of slides, overheads, etc. as needed for department, project, and sponsor and or business development.
- Performs other duties as assigned.
Applied Knowledge & Skills:
- Needs a basic understanding of the conduct of clinical trials, related systems, and procedures, and guidance and regulations.
- Ability to write clearly and succinctly; must be able to accurately record meeting minutes and action items.
- Must have excellent interpersonal and communication skills and demonstrate the ability to work successfully in a team environment.
- Ability to prioritize and manage multiple tasks.
- Familiar with applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- 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.
- Demonstrated effective organizational skills.
- Demonstrated strong attention to detail.
- Must be able to read, write and speak fluent English.
Problem Solving & Impact:
- Works on problems of limited scope that require a review of various factors.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Decisions generally affect own job or specific functional area.
- Receives general instructions on routine work, detailed instructions on new projects or assignments.
- Does not have direct supervision responsibilities.
- Typically reports to a Manager/Associate Director.
- High School/GED Diploma or its International Equivalent in Education, Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field.
- Bachelor's Degree preferred.
- Typically requires a minimum of 0 - 3 years’ experience in clinical research, other research or health care related field.
- Related prior work experience preferred. Prior work in a non-governmental organization (NGO).
- Non-governmental organization (NGO) experience preferred.
Typical Physical Demands:
- Typical office environment.
- Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
- Ability to sit and stand for extended periods of time.
- Ability to lift 5 - 50 lbs.
Technology to be Used:
- Personal Computer, Microsoft Office 365 (i.e. Word, Excel, PowerPoint, e-mail), office telephone, cell phone and printer/copier.
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.
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About FHI 360
FHI 360 is an international nonprofit working to improve the health and well-being of people in the United States and around the world.
We partner with governments, the private sector and civil society to bring about positive social change and to provide lifesaving health care, quality education and opportunities for meaningful economic participation. We do this by using research and evidence to design and deliver innovative programs that change behaviors, increase access to services and improve lives.
Our staff of more than 4,000 professionals work in more than 60 countries. Their diverse technical expertise and deep understanding of local conditions provide a 360-degree perspective that allows us to develop customized responses to the toughest human development challenges.