Are you looking for an exciting opportunity to make an impact during the current Covid-19 pandemic? FHI 360 is looking for a Research Associate for the new COVID-19 Prevention Network (CoVPN). CoVPN was formed to evaluate vaccines and monoclonal antibodies for prevention of SARS-CoV2 infection and the resulting COVID-19 disease. COVID-19 is having a profound impact on families and communities that will last for years to come. From the urgent need for pandemic control and response, to the expanded demand for distance learning, to the eventual rebuilding of economies — FHI 360 will be here through it all. COVID-19 may be new to the world, but our ability to respond quickly to emerging Infectious Diseases is not. If you are looking for stimulating work in the clinical research arena and want to make an impact on the world, then look no further and apply now.Apply Now
Job Summary:The Research Associate I 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.
- 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.
- 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.
- Bachelor’s Degree or its International Equivalent - Knowledge/Information Services, Communications, Education, Environment, Health, Behavioral, Life/Social Sciences International Development, Human Development or Related Field.
- Master’s preferred.
- Typically requires 3-5 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.