Quality Assurance Specialist II – COVID-19 Prevention Network
FHI 360 (FHI 360)
Location: Durham (United States)
H Hardship
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Added 1 week ago
Job Description

Job Summary:

The Quality Assurance (QA) Specialist is a member of the COVID-19 Prevention Network (CoVPN) Leadership and Operations Center (LOC) team and works with FHI360 senior staff to develop, implement, and conduct the spectrum of quality assurance, regulatory, and compliance activities for clinical research studies. The position will be responsible for ensuring compliance with applicable regulatory requirements and industry standards, supporting audit preparation and investigations, reviewing/analyzing compliance data, and supporting project team needs.

Staff within the Science Facilitation Department of FHI 360 serve as the LOC for the US National Institutes of Health (NIH)-sponsored CoVPN. The LOC is responsible for contributing to and supporting the development, implementation and reporting of a subset of CoVPN clinical trials and for providing coordination, communications, and support to the CoVPN leadership. The LOC is also responsible for arranging and supporting meetings and communications, and for providing logistical and administrative support to the CoVPN, as needed.

Staff from the LOC work closely with CoVPN staff from the statistical and data management support center(s), laboratory support center(s), NIH, pharmaceutical partners, study teams, clinical research sites and their community programs on various aspects of the CoVPN scientific research agenda.

Accountabilities:

  • Assisting with eTMFs including QA/QC, periodic reviews and ensuring consistency across studies, to the extent possible
  • Reviewing sites’ documentation/certificates and completing the required checklist for the study activation purposes
  • Liaising and assisting with single IRB (sIRB) coordination, submission, and communication (between relying sites and the sIRB administrator)
  • Monitoring continuing IRB review 
  • Tracking staff training and delegation documentation for studies and general training (and routine QA/QC of our internal training files, for example, CV updates, etc.)
  • Conducting routine (~annual) internal audits of our files/systems
  • Formatting (or confirming appropriate formatting) of protocols and other documents for eCTD compliance
  • Collect and save Investigator Brochure documents
  • clinicaltrials.gov management for all non-IND studies
  • Provide input for and revisions of assigned related documents including Standard

    Operating Procedures (SOPs), Work Instructions (WIs) and reports

  • Support maintenance of the quality management system
  • Keeps current on regulations and guidance.
  • 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 clients 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 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.

Supervision Given/Received:

  • Has no supervisory responsibility
  • Receives general instructions on routine work, detailed instructions on new projects or assignments.
  • Typically reports to a Manager/Associate Director.

Education:

  • Bachelor's Degree or its International Equivalent in Health, Behavior, Life/Social Sciences International Development, Human Development or Related Field. Master’s degree preferred.

Experience:

  • Typically requires 3 - 5 years of quality assurance, compliance, regulatory, or related experience.
  • Non-governmental organization (NGO) experience preferred.

Typical Physical Demands:

  • Typical office environment.
  • Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
  • Ability to sit and stand for extended periods of time.
  • Ability to lift 5 - 50 lbs.

Technology to be Used:

  • Personal Computer, Microsoft Office 365 (i.e. Word, Excel, PowerPoint, e-mail), office
    telephone, cell phone and printer/copier.

Travel Requirements:

  • Less than 10%

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.
 

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.