FHI 360

Clinical Research Assistant

FHI 360

Job Description

Clinical Research Assistant I– HPTN Network Job Summary: The Research Assistant is a member of the HPTN Leadership and Operations Center team and assists with implementation and maintenance of clinical trials and other research-related activities. Maintains, updates, and may establish various databases for tracking research studies. Maintains research files and files study documents in an electronic database. Responsible for ordering and shipping of supplies. Coordinates, reviews and develops study related documents and assists with clinical research site communication, and implementation of study components based on standard operating procedures (SOPs). Staff within the Science Facilitation Department of FHI 360 serve as the Leadership and Operations Center for the US National Institutes of Health (NIH)-sponsored Hiv Prevention Trials (HPTN) Network. The Leadership and Operations Center is responsible for contributing to and supporting the development, implementation and reporting of all HPTN clinical trials and for providing a central point of Coordination, communications, and support to the HPTN Executive Committee and all network committees, protocol teams, and working groups. The Leadership and 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 HPTN Executive Committee and other committees. Staff from the Leadership and Operations Center work closely with the HPTN staff from the Statistical and Data Management Center (SDMC), Laboratory Center (LC), Clinical Research Sites, Division of AIDS (DAIDS) within NIAID, network committees, working groups, study teams, clinical research sites and their community programs on all aspects of the HPTN Scientific Research agenda. Accountabilities:
  • Coordinates, tracks and edits assigned study-related documents including protocols, procedures manuals, reports, and publications.

  • Conducts document reviews to ensure quality and compliance standards.

  • Uploads files into an electronic database.

  • Assists with development of study site training materials and presentations

  • Maintains central files, dossiers for IRB reviews.

  • Communicates with clinical research site staff to ensure information is received and to track completion of study milestones.

  • Performs administrative duties including setting up conference calls, preparing conference call and meeting summaries, ordering supplies, and assisting with meetings and travel plans.

  • Performs other related duties as assigned.

Problem Solving & Impact:
  • Works on assignments that are varied 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.

  • Associate degree or its International Equivalent - Health, Behavioral, Life/Social Sciences or Related Field.

  • MPH or equivalent strongly preferred.

  • 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.

  • Must be able to read, write and speak fluent English; fluent in host country language as appropriate.

  • Prior work experience in a non-governmental organization (NGO), government agency, or private organization.

Travel Requirements:
  • 10%-25%

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