Scientist I, Clinical Research
Durham | Washington D.C
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: Scientist, Clinical Research
Responsible for conceptualizing, initiating, directing, and executing scientific research and/or development strategies in research studies and product development projects. Investigates the feasibility of applying a wide variety of scientific principles, methods, and concepts to studies, problems, and projects. Makes major contributions to scientific literature and conferences. Acts as spokesperson on corporate research studies and scientific projects and advises executive management. Interfaces with various departments and serves as an internal consultant.
Job Summary / Responsibilities:
- Develops scientifically appropriate approaches to answering a variety of research questions.
- Responsible for the planning, implementation, execution and management of one or more clinical research studies by:
- Leading the study team to design, develop and deliver the clinical study to meet agreed upon timelines
- Being responsible for oversight of identification and selection of investigator sites
- Planning and executing training for research studies for internal and external collaborators including the development of training materials
- Managing outsourcing to CROs and other vendors such as labs, safety management, etc.
- Authoring and reviewing essential study documents (study protocols, analysis plans, data collection tools, etc.)
- Drafting, reviewing and presenting analysis of research findings and reports for publication and training materials
- Being ultimately responsible for the financial management of a study, and developing and overseeing study timelines
- Overseeing medical monitoring/safety management
- Provides in-house review of protocols, papers, research strategies and proposals for funding projects for methodological and technological soundness.
- Evaluates issues, interprets data, and suggests and implements solutions and mitigation as required.
- Collaborates with higher level scientists on various research materials, statistical results, and medical/clinical agendas.
- Conducts medical monitoring for clinical trials implemented in the department.
- MD and 5+ years obstetrics/gynecology postgraduate training and with scientific disciplines developing strategies in research studies and scientific projects.
- 2+ years of experience in clinical research (may be during fellowship training).
- Knowledge of clinical pharmacology desirable.
- Experience in drug development desirable.
- Comprehensive knowledge of theories, concepts and practices used in analysis of clinical research studies, preferably clinical trials.
- Demonstrated technical skills, scientific creativity, collaboration with others and independent thought.
- Ability to work in a team environment with others, including internal staff, clinical research sites, and other external research partners.
- Familiarity with analysis of quantitative data.
- Excellent quantitative/qualitative and analytical skills.
- Excellent oral and written communication skills.
- Ability to analyze and interpret data, identify errors and provide correction action.
- Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
- Ability to analyze data, identify errors and provide corrective action.
- Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
- Must be able to read, write, and speak fluent English.
- Prior work experience in a non-governmental organization (NGO) or in work-related academic, governmental, or industry setting.
- Travel requirements: 10-15%
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.
We offer competitive compensation and an outstanding benefit package. Please click here to visit FHI 360's Career Center for a list of all open positions.
FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is an equal employment 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, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.
- Organization: FHI 360
- Location: Durham | Washington D.C
- Grade: Mid/Senior
- Health service
- Health service
- Closing Date: 2016-04-30