Clinical Advisor

Profile

Clinical Advisor

Duties: Work closely with federal staff to 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. Develop frequently asked questions and other informational and guidance documents derived through DAIDS experience in processing CTAs. Assist federal client in developing Memoranda of Understanding (MOU) and Interagency Agreements (IAA) to support Division’s goals.

Additional Information

Reference Code: 0164-NIAID-CA-2020

Company info

Oak Ridge Associated Universities, Inc
130 Badger Road
Oak Ridge
Tennessee
United States 37830
Website : http://www.orau.org