Job opening ID
Roles and responsibilities
Must be a US Citizen
Some travel may be required.
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 Advisor to work onsite with the National Institutes of Health in Rockville, 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
The contractor shall:
• Implement and coordinate a range of individual clinical site-management activities
• Advise PIs on clinical site start-up and relevant operational and regulatory issues including resource allocation, personnel management, and administrative issues
• Provide leadership for planning, organizing, and conducting site visits or reverse site visits to clinical trials units to effectively fulfill site management responsibilities.
• Assess the level of clinical trials research competency of clinical research sites and the extent of research knowledge and technology available to achieve the desired quantity and quality of the clinical trials units.
• Direct and conduct formal evaluations of the clinical trials units’ organizational structures and modes of operations in relationship to the achievement of the Division’s goals and objectives in the areas of administration, clinical site management, and recruitment of patients.
• Provide oversight and technical direction for evaluation of site performance using data com-piled by the network data management centers.
• Identify problems or issues that transcend individual units or trends that indicate the need for procedural clarification or policy development and recommends follow-up actions or policy directives to OCSO Director or Branch Chief
• Conduct trainings at sites and Network meetings on relevant policies/regulations
• Attend Network meetings, conference calls, ad hoc meetings and working groups.
• Support federal Program Officers by: 1) tracking and summarizing grantee compliance with training requirements, grantee progress in meeting the grant aims by reviewing progress re-ports, and adherence to applicable regulations; and 2) reviewing training manuals, policies and procedures
• Participate in the creation and review of study or site closure-related documents and check-lists
• Interface with networks, investigators, Operations Centers, to share information and collaborate on research and site-related issues
• Prepare oral and written presentations for internal and external programmatic and scientific meetings
• Must be a US Citizen
• Offer contingent on ability to successfully pass a background check and drug screen
• Master’s degree in a related discipline. Three (3) years of specialized experience plus a Bachelor’s degree is equivalent to a Master’s degree.
• Minimum of nine (9) years of experience in the health-care professional education field.
• Experience with Microsoft Office.
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