fhi360 Research Associate I - IMPAACT Network in Durham, North Carolina
Performs research development with senior research staff to develop, implement, manage, and conduct research studies. Makes detailed evaluations, observations, analyzes data and interprets results using qualitative/quantitative methods and statistics. Investigates, creates and develops new methods and technologies for project advancement.
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.
Staff from the Operations Center work closely with the IMPAACT leadership, staff from the Statistical and Data Management Center (SDMC), Laboratory Center (LC), Clinical Research Sites, 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.
Operations Center responsibilities include:
• Leadership and Governance Support• Research Management and Support• Protocol Development and Review• Protocol Specific Training of Clinical Research Sites• Oversight of Clinical Research Sites prior to and during Study Conduct• Coordination and Facilitation of Network Committees• Communication and Information Dissemination
Works with senior research staff to develop, implement, manage, and conduct clinical trials. Investigates, creates and develops new methods and technologies for project advancement.
Prepares research concepts and proposals following established policies and procedures.
Serves as member of protocol teams and contributes to development of study protocols, informed consent forms, study procedures manuals and other study related documents.
Assists with the design and implementation of research studies.
Ensures compliance with government regulations when writing and reviewing protocols, analysis plans, reports, and manuscripts.
Develops training materials and conducts training for study implementation based on company and network policies and standard operating procedures (SOPs).
Provides input with questionnaire development, study design, and material management.
Plans, organizes, and manages resources/processes for successful completion of study goals.
Communicates with clinical research sites and tracks and reports their in completing study activation requirements, and other study implementation metrics.
Facilitates and contributes to the work of scientific committees.
Applied Knowledge & Skills:
Working knowledge of concepts, practices and procedures for conducting clinical trials research studies under government regulations (e.g., US FDA)
Strong knowledge of software programs used to perform data reviews.
Strong technical writing skills.
Excellent oral and written communication skills.
Ability to analyze and interpret data, identify errors and prepare reports.
Problem Solving & Impact:
Works on problems of moderate 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.
Typically reports to a Manager/Director.
Master's Degree preferred - Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field.
Bachelor's Degree or its International Equivalent • Education, Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field.
Typically requires 3-5 years of clinical research or evaluation experience.
Proficiency in Microsoft Office, spreadsheet software and other technology required.
Articulate, professional and able to communicate in a clear, positive fashion with external collaborators, sponsors and staff.
Must be able to read, write and speak fluent English.
Related prior work experience required.
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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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, technology, communication and social marketing — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.
As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.