fhi360 Clinical Research Assistant - IMPAACT network in Durham, North Carolina
The Research Assistant is a member of the IMPAACT 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 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 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
Coordinates, develops, reviews, tracks and revises assigned study-related documents including protocols, SOPs, monitoring plans, analysis plans, reports, and publications.
Conducts document reviews to ensure quality and compliance standards.
Assists with development of study site training materials and presentations, prepares conference call summaries.
Develops and maintains central files, dossiers for IRB reviews, and sets up conference calls.
Communicates with clinical research site staff to ensure updates and the successful completion of study goals.
Performs administrative duties, assists 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.
Has no supervisory responsibility.
Follows established procedures on routine work, receives instruction on new assignments.
Typically reports to a Manager.
MPH or equivalent strongly preferred;
Associate’s Degree or its International Equivalent - Health, Behavioral, Life/Social Sciences or Related Field.
Typically requires 1-2 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.
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.
Please click here to continue searching FHI 360's Career Portal.FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is an equal employment 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, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.
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.