Research Associate II - COVID-19 Prevention Network
FHI 360 (FHI 360)
Location: Durham (United States)
Grade: General Support
H Hardship
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Added 6 days ago
Job Description

Job Summary:

The Research Associate II is a member of the COVID-19 Prevention Network (CoVPN) Leadership and Operations Center (LOC) team and is responsible for the overall coordination and management of clinical studies from start up through close out activities. Directs the technical and operational aspects of the projects, ensuring the successful completion of clinical studies. Works with major functional area leads to identify and evaluate fundamental issues on the project, make good business decisions and ensure solutions are implemented. Works to ensure all project deliverables meet the sponsor's time/quality/cost expectations. The RA works in collaboration with other functional area leads providing accurate labor forecasts, reviewing pass through costs and ensuring timely invoicing. S/he effectively creates operational project plans tailored to the particular needs of each assigned study. Ensures that project progress and deliverables meet contractual requirements. Ensures that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with Standard Operating Procedures (SOPs), Work Instructions, policies and practices.

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:

  • Prepares research concepts and proposals following established policies and procedures.
  • 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 policies and standard operating procedures (SOPs).
  • Provides input with questionnaire development, analysis, study design, and material management.
  • Plans, organizes, and manages resources/processes for successful completion of study goals.
  • Develops protocols and informed consents for research studies. Provides guidance on any protocol related issues.
  • Assists finance team with developing the study budget.
  • Develops, reviews, and maintains key study documents to ensure adequate documentation.
  • May act as team lead and mentors staff on training, systems, policies, and regulations.
  • Serves as the liaison with internal and external partners to ensure effective collaboration efforts.
  • Oversees planning of meetings, site visits, and drafting necessary documents.

Applied Knowledge & Skills:

  • Working knowledge of concepts, practices and procedures for conducting research studies under government regulations.
  • Excellent oral and written communication skills.

Problem Solving & Impact:

  • Works on problems of diverse scope that require analysis or interpretation of identifiable factors.
  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
  • Decisions may affect a work unit or area within a department.

Supervision Given/Received:

  • Receives methods and procedures on new studies.
  • Provides suggestions on business and operational decisions that affect the department.
  • Serves as team lead to team members.
  • Typically reports to a Manager/Director.

Education:

  • 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.

Experience:

  • Typically requires 5-8 years of research or evaluation experience with manuscripts, and study implementation.
  • Proficiency in Microsoft Office. 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.
  • Related prior work experience preferred.

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.

Travel Requirements:

  • 10%-25%

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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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.