Fhi 360, Durham NC, United States
Closing Date for Applications:
Provide support to the Infectious Diseases Clinical Research Consortium (IDCRC) Leadership Group. IDCRC is a newly funded NIH award to support the planning and implementation of clinical research that addresses the scientific priorities of NIAID in evaluating vaccines, other preventive biologics, therapeutics, diagnostics, including prognostics and predictive markers, and devices or the treatment and prevention of infectious diseases (malaria/neglected tropical diseases, sexually transmitted infection, respiratory infection and enteric diseases).
This position will provide support and assist with the implementation and maintenance of research studies; maintain, update, and may establish various databases for tracking research studies; maintain research files and may be responsible for ordering and shipping of supplies in coordination with all phases of the studies; coordinate, review and develop study-related documents and assist with data management processes, site communication, and implementation of study components based on standard operating procedures (SOPs).
- Supports the Research Associate
- Coordinates, develops, reviews, tracks and revises assigned study-related documents including protocols, SOPs, reports, and publications.
- Conducts data reviews to ensure quality and compliance standards.
- Performs administrative duties of purchasing supplies, assisting with meeting and travel arrangements, and preparing training materials and presentations as needed.
- Collects and tracks essential regulatory documents, develops and maintains central files using various databases (SERD, eTMF, SharePoint), and reviews dossiers for IRB submission.
- Sets up conference calls and drafts meeting minutes.
- Distributes study-related information, updates, and documents to the study team/coordinates posting on website or portal.
- Supports, documents, and tracks various network processes (e.g., concept development and review, site selection, site performance) as needed.
- Communicates with site staff to ensure the successful completion of study goals.
- Performs other related duties as assigned.
- Associate’s Degree or its International Equivalent • Knowledge/Information Services, Communications, Education, Health, Behavioral, Life/Social Sciences International Development, Human Development or Related Field.
- Typically requires 0-2 years of clinical trial or public health research experience.
- 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.