Clinical Research Coordinator

Job opening ID
2836

Posting title
Clinical Research Coordinator

Roles and responsibilities
Must be a US Citizen or Green Card Holder
Some travel may be required
Offer contingent on ability to successfully pass a background check and drug screen   

Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Columbus offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking Clinical Research Coordinator to work onsite with the National Institutes of Health in Bethesda, MD.

This is a long-term position which offers:
- Competitive salary
- Tremendous growth opportunity
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Columbus can do for you at www.columbususa.com

Job Description: 
The contractor shall:
• Serve as Human Research Protection Specialist in the NIMH Human Research Protection Branch.
• Serve as advisor to the NIMH Office of Clinical Research (OCR) staff and colleagues.
• Serve as a resource for ethical and regulatory inquiries in the field of mental health research.
• Evaluate human research protection plans and data and safety monitoring plans.
• Serve as Scientific Administrator for the NIMH Data and Safety Monitoring Boards (DSMBs).
• Provide advice to staff in designing data and safety monitoring plans for NIMH-funded clinical trials.
• Identify inadequacies and inconsistencies in scientific and regulatory data.
• Develop and deliver training/education to key stakeholders; develop extramural human research protection policies and standard operating procedures.
• Provide advice to NIMH Director of Clinical Research (DCR) and NIMH Program Officials on National Advisory Mental Health Council applications and policy matters related to human subject protection.
• Independently research background information regarding clinical research ethics and federal human subject protection regulations.
• Interpret findings of the analyses; prepare reports and informational materials for presentation to management, other governmental and non-governmental agencies, scientific meetings, Data and Safety Monitoring Board meetings, etc.
• Identify, document and resolve critical human subject protection issues.
• Prepare meeting agendas and meeting summaries; coordinate meeting plans.
• Interpret findings of analyses; prepare reports and information materials for presentation
• Interpret regulations and guidance from various federal agencies as related to research projects and programs.
• Provide guidance to DCR and NIMH Program Officials regarding a variety of complex and sensitive mental health issues covering the full range of NIMH program areas, especially clinical research and issues such as research ethics, informed consent, vulnerable research participant populations, review and evaluation of unanticipated events, and other human research protection issues.

Required Skills: 
The contractor must have:
• Ph.D. in a Science or Health related discipline; three (3) years of specialized experience plus a Master’s degree is equivalent to a Ph.D.
• Minimum of three (3) years of experience working in a human research protection program such as an Institutional Review Board office or as a clinical research policy advisor.
• Expert knowledge of Microsoft Office Suite (MS Word, Excel, Outlook, PowerPoint, SharePoint) and database searches.
• Excellent communications skills, both oral and written.
• Excellent analytical, organizational and time management skills.


Number of positions
1

Location
Bethesda

State
Maryland