Job Summary:

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 primary role of the Research Assistant is to assist clinical research teams by developing study specific documents, creating and maintaining filing and tracking systems to coordinate study progress, drafting and issuing meeting summaries, and facilitating communications. All activities performed are under supervision by senior staff.

Accountabilities:

• Coordinates, develops, reviews, tracks and revises assigned study-related documents including protocols, SOPs, monitoring plans, analysis plans, and reports.
• Conducts document reviews to ensure quality and compliance standards.
• Assists with development of study site training materials and presentations
• Develops and maintains shared filing systems (e.g., SharePoint, MS Teams); collecting and filing essential documents (e.g., in the study-specific electronic Trial Master File [eTMF]).
• Sets up conference calls, drafts and issues meeting summaries, including action items and decisions; tracks action items to resolution.
• Develops and maintains email alias lists.
• Communicates with clinical research site staff to ensure updates and the successful completion of study goals. Provides technical assistance to clinical research sites and study staff, including review of materials, site updates, and query resolution.
• Tracks publications and reviews; coordinating manuscript submissions.
• Performs administrative duties; assists with meetings and travel plans.
• Performs other related duties as assigned.

Problem Solving & Impact:

• Works on assignments that are multifaceted in scope that require analysis or interpretation of the situation.
• Exercises good judgment within established procedures and practices to solve problems.
• Decisions may affect a work unit or area within a department.

Supervision Given/Received:

• Has no supervisory responsibility.
• Follows established procedures on routine work, receives instruction on new assignments.
• Typically reports to a Manager.

Education:

• Associate’s Degree or its International Equivalent in Health, Behavioral, Life or Social Sciences or other fields related to international/human development.
• Bachelor’s Degree, or MPH or equivalent, strongly preferred

Experience:

• Typically requires 0-2 years of clinical trial or public health research experience; 1+ year of clinical trials or public health research experience strongly preferred.
• Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
• Able to read, write and speak proficient English

Typical Physical Demands:

• Typical office environment.
• Ability to sit or stand for extended periods of time.
• Ability to move 5-10 lbs.

Technology to be Used:

• Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail (Outlook)

Travel Requirements:

• Up to approximately 10%

This job posting 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.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

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