Performs clinical research development activities with senior research staff to develop, implement, manage, and conduct clinical research studies (from approval of concepts through data analysis and manuscript submission) for the Infectious Disease Clinical Research Consortium (IDCRC). Makes detailed evaluations and observations, analyzes data and interprets results using qualitative/quantitative methods and statistics. Investigates, creates and develops new methods and technologies for project advancement.
Assists with the development, review, approval, and maintenance of all documents required for study implementation (i.e., protocol, informed consents, manual of procedures, data collection forms, and other study-specific standard operating procedures (SOPs) or appropriate documentation).
Facilitates and documents team calls, keeping a written record of major decisions.
Maintains close contact with site teams and Sponsor representative(s) throughout the study.
Initiates essential study documents collection and communicates frequently with study sites throughout the study to ensure maintenance of required document renewals and for changes in study staff or sites.
Ensures timely reporting and completion of deliverables as appropriate.
Assists with the design and implementation of research studies, including the sampling, recruitment, and statistical analysis.
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 sponsor policies and SOPs.
Provides input with questionnaire development, analysis, study design, and material management.
Plans, organizes, and manages resources/processes for successful completion of study goals.
Applied Knowledge & Skills:
Working knowledge of concepts, practices and procedures for conducting clinical research studies under government regulations.
Strong understanding of Good Clinical Practice (GCP) and Human Subjects Protection (HSP)
Strong understanding of software programs used to collect data and perform data analysis and reviews.
Excellent oral and written communication skills.
Ability to analyze and interpret data, identify errors and prepare reports.
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.
Receives general instructions on routine work, detailed instructions on new projects or assignments.
Typically reports to a Manager/Director.
Bachelor's Degree or its International Equivalent • Education, Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field.
Typically requires 3-5 years of clinical research experience.
Proficiency in Microsoft Office, spreadsheet software, SharePoint and other technology required.
Articulate, professional and able to communicate in a clear, positive fashion with sponsors, external collaborators and staff.
Must be able to read, write and speak fluent English. Related prior work experience required.
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, PDAs and other handheld devices.
This job posting 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 is an equal opportunity 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, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.
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Internal Number: 2020201650
About FHI 360
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.
FHI 360 is an equal opportunity 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, physical or mental disability, protected Veteran status, or any other char...acteristic protected under applicable law.
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