Senior Clinical Research Advisor

Axle is seeking a Senior Clinical Research Advisor to join our vibrant program team supporting the National Center for Advancing Translational Sciences (NCATS), Division of Clinical Innovation (DCI), Clinical and Translational Science Awards (CTSA) Program located in Bethesda, MD. The CTSA Program is the single largest research program at the National Institutes of Health (NIH). Through this program, the Division of Clinical Innovation (DCI) within NCATS invests annually to promote new methods and technologies that address bottlenecks and enhance the translational research pipeline to speed the delivery of new drugs, diagnostics and medical devices to patients. Currently, more than 50 medical research institutions across the nation receive CTSA Program funding toward this mission.

The selected individual shall provide the DCI Director with senior-level scientific program support in accomplishing the CTSA goals and objectives. 
 
Responsibilities:

• Perform scientific program management support services virtually and/or onsite at the NIH in coordination with the DCI Director.


• Apply expert knowledge and educational background in clinical research and translational medicine to support and coordinate vital activities executed by the DCI Trial Innovation Network (TIN), including surveillance of 50+ program hub award institutions.


• Collaborate with NCATS and DCI to develop new TIN Funding Opportunity Announcements (FOAs).


• Explore and contrast existing NIH funding mechanisms as potential formats.


• Collaborate with DCI staff to gather data pertinent to the development of new TIN FOA(s).


• Analyze data and identify gaps and opportunities.


• Identify opportunities for synergy and collaboration with external stakeholders.


• Collaborate with the NIH Office of Extramural Research (OER), program, and review staff to obtain necessary information.


• Establish and oversee DCI working groups to review and make recommendations regarding existing and new TIN FOA components.


• Develop presentations and reports; develop metrics for strategic management of the TIN.


• Support the administration of several large awards in the TIN program.


• Contribute expertise and knowledge to DCI in support of its efforts to foster innovation and deliver national leadership in the growing area of clinical and translational science (CTS), which is a distinct research discipline.


• Participate with DCI leadership in expanding its advocacy and sponsorship of initiatives related to excellence in data management and innovative approaches to the management and standardization of translational research data.


• Assist in expanding DCI’s collaboration with other NIH Institutes/Centers (ICs) and the scientists they support, and foster efforts that strengthen communication among stakeholders across the clinical spectrum, including patients, industry, and regulators.

 
Qualifications:  

• Medical degree from an accredited university.


• Board certified and licensed in a medical-related field or D.D.S. in a state, territory or commonwealth of the United States or District of Columbia.


• Ten (10) years of experience in clinical trial research.


• Required prior involvement in clinical trials as an investigator or medical monitor.


• Well-versed in multiple disciplines, including the broad application of information technology; interpretation of information from a wide variety of sources including biological sequences and molecules; potential research uses of electronic health records (EHR); and issues related to clinical studies, clinical trials, and rare diseases.


• Familiar with National Institutes of Health (NIH) and Department of Health and Human Services (HHS) human subjects’ policies; Institutional Review Board (IRB) policies and subject safety; and data sharing and confidentiality issues.


• Familiar with specific NIH grant mechanisms (e.g. UM1, U24, etc.).


• Expertise in clinical trials, basic research, management of large networks, and have regulatory experience.


• Expert knowledge of clinical research and care in academic and/or community clinical settings.


• Educational background and training in clinical medicine are paramount.


• Experience in establishing and promoting a vision of innovation in the growing area of clinical and translational science is critical.


• Demonstrated track record of applying translational science concepts to deliver innovative solutions to clinical research problems while working collaboratively and utilizing a consultative approach to problem solving and decision.