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 Quality Assurance (QA) Specialist is a member of the IMPAACT Operations Center team and works with other staff to develop, implement, and conduct the spectrum of quality assurance, regulatory, and compliance activities for clinical trials and ancillary studies. The position will be responsible for ensuring compliance with applicable regulatory requirements and industry standards, supporting audits and investigations, reviewing/analyzing data, and supporting project team needs.
- Develop, review, and revise assigned related documents including Standard Operating Procedures (SOPs), work instructions, and reports.
- Oversee internal audits and accreditation activities.
- Ensure that a quality management system is maintained and provide input on potential improvements to the system.
- Serve as a liaison with internal and external partners to ensure effective collaboration efforts.
- Collect materials for and help maintain files and information management systems.
- Support the development of quality systems for QA oversight and processes.
- Assist with the set-up and maintenance of eTMFs, including QA/QC and periodic reviews, and ensure consistency across studies, to the extent possible.
- Review sites' clinical trials insurance documentation/certificates and complete the sponsor's required checklist for study activation purposes.
- Manage and track the submission and review of proposals from external investigators for use of specimens and data from completed network studies in new investigations, including evaluating consent forms and resource requests and handling all related correspondence, etc.
- Contribute to management and implementation of the protocol deviation reporting process that is in place, coordinating with the IMPAACT SDMC, including evaluating reports for completeness and clarity, following up with sites as needed and reporting to the NIH sponsor and network leadership.
- Track general staff training and delegation documentation for studies including routine QA/QC of internal training files, for example, CV updates, etc.
- Liaise and assist with single IRB (sIRB) coordination and communication (between relying sites and the sIRB administrators and coordinator) as needed.
- Conduct routine (every other year) internal audits of project files/systems.
- May act as team lead and mentor staff on training, systems, policies, and regulations.
- Formatting (or confirming appropriate formatting) of protocols and other documents for eCTD compliance.
- Support maintenance of the Quality Management System.
- Keep abreast of current applicable regulations and guidance.
- Perform other duties as assigned.
Applied Knowledge & Skills:
- Working knowledge of concepts, practices, and procedures for conducting quality assurance activities according to industry standards.
- Strong knowledge of software programs used to perform data analysis and reviews.
- Excellent oral and written communication skills.
- Proficiency in Microsoft Office, databases, spreadsheet software and other technology required.
- Articulate, professional and able to communicate in a clear, positive fashion with collaborators, sponsors and staff.
- Ability to analyze and interpret data, identify errors and prepare reports.
- Must be able to read, write, and speak fluent English.
Problem Solving & Impact:
- Works on problems of diverse scope that require analysis or interpretation of identifiable factors.
- Exercises good judgment in selecting methods and techniques for obtaining solutions.
- Decisions may affect a work unit or area within a department.
- Master’s Degree or its International Equivalent • Knowledge/Information Services, Communications, Education, Environment, Health, Behavioral, Life/Social Sciences International Development, Human Development or Related Field.
- Typically requires 4-8 years of quality assurance, laboratory, or related experience.
- Proficiency in Microsoft Office, databases, spreadsheets, analytical software, and other technology required.
- Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.
- Must be able to read, write and speak fluent English.
- Receives methods and procedures on new on routine work, detailed instructions on new projects or assignments.
- Provides suggestions on business and operational decisions that affect the Operations Center.
- Serves as team lead to team members.
- Typically reports to a Manager/Associate Director.
Typical Physical Demands:
- Typical office environment.
- Ability to sit and stand for extended periods of time.
- Ability to lift 5-50 lbs.
Technology to be Used:
- Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, etc.
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.
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About FHI 360
FHI 360 is an international nonprofit working to improve the health and well-being of people in the United States and around the world.
We partner with governments, the private sector and civil society to bring about positive social change and to provide lifesaving health care, quality education and opportunities for meaningful economic participation. We do this by using research and evidence to design and deliver innovative programs that change behaviors, increase access to services and improve lives.
Our staff of more than 4,000 professionals work in more than 60 countries. Their diverse technical expertise and deep understanding of local conditions provide a 360-degree perspective that allows us to develop customized responses to the toughest human development challenges.