Sr. Clinical Advisor
Job opening ID
Sr. Clinical Advisor
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 a Sr. Clinical Advisor to work onsite with the National Institutes of Health in Rockville, MD.
This is a long-term contract 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
•Develop and implement Clinical Trials Agreements (CTAs), Confidential Disclosure Agreements (CDAs), and other critical agreements with external stakeholders involved in the conduct of clinical research sponsored by the Division of AIDS.
•Develop recommendations for positions, and solutions to resolve issues that arise involving established agreements or agreements being processed.
•Maintain adherence to DAIDS-wide policies, standard procedures, and guidance documents on all aspects of agreements necessary for DAIDS clinical research and relevant topics.
•Ensure documents are in accordance with Federal Guidelines on Inherently Governmental Functions and NIH Policy on Relations with the Office of General Counsel.
•Provide support to DAIDS staff, investigators, and collaborators on clinical research agreements, including the choice of the type of agreement to be selected, and any legal/regulatory issues that arise.
•Collaborate with other components of NIAID and NIH, including the Office of General Counsel and the NIAID Office of Technology Development (OTD) to harmonize CTA templates and provisions across various divisions of NIAID and to address issues that arise in agreement processing.
•Establish methods to evaluate the effectiveness and timeliness of the development of clinical research agreements and to ensure the compliance of agreements with established requirements, standards, and procedures.
•JD degree and at least 3 years of experience negotiating clinical research agreements (CTAs, MTAs, CDAs, etc.)
•Minimum of nine (9) years of experience in the health-care professional education field.
•Knowledge of federal regulations pertaining to clinical research
•Knowledge and skill in applying analytical and evaluative methods and techniques to complex and controversial issues for the purpose of supporting development of new and revised policies and standard procedures on clinical research agreements.
•Excellent oral and written communication skills
•Strong organizational skills and the ability to work independently and as part of a team.
•Background in biological science
•Pharma or federal experience
Number of positions