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). Makes detailed evaluations, observations, analyzes data and interprets results using qualitative/quantitative methods and statistics. Investigates, creates, and employs methods for tracking project advancement.
- Leads the development, review, 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).
- Assists with the design and implementation of clinical research studies, including the sampling, recruitment, and statistical analysis.
- Ensures compliance with government regulations when writing and reviewing protocols, consent forms, analysis plans, reports, and manuscripts.
- Provides input with questionnaire development, analysis, study design, and material management.
- Plans, organizes, and manages resources/processes for successful completion of study goals.
- 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.
- Develops training materials and conducts training for study implementation based on sponsor policies and SOPs.
- Provides guidance on any protocol related issues.
- Manages and oversees budget for one or more clinical research projects.
- 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 clinical research studies under government regulations.
- Strong understanding of software programs used to collect data and perform data analysis 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 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.
- Master’s Degree or its International Equivalent, Health, Behavioral, Life/Social Sciences International Development, Human Development or Related Field.
- Typically requires 5-8 years of clinical research experience to include protocol development and study implementation.
- Proficiency in Microsoft Office, 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 hand held 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.
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
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About the Organization
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 and technology — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 70 countries and all U.S. states and territories. We are currently seeking qualified candidates for the position of: Research Associate