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Job Runner

 
  • Category: Healthcare
  • Education: Bachelors Degree
  • Employment Length: fulltime
  • Location: Rockville MD
  • Source: Business
  • Ad #: 13563
 
Via: kellyjobsmnetwork Apply / More Info
 
Full Details

Clinical Advisor – NIH – Rockville, MD

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions 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 Clinical Advisor to support the National Institutes of Health in Rockville, MD.

This is a long-term contract position which offers:
- Competitive salary with comprehensive benefit package
- Opportunity to work at NIH, world's foremost medical research center
- Learn more about what Kelly can do for you at http://www.kellygovernmentsolutions.com

TASKS/SERVICES: The contractor shall:

  • 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 DMID.
  • Develop recommendations for positions, and solutions to resolve issues that arise involving established agreements or agreements being processed.
  • Maintain adherence to DMID-wide policies, standard procedures, and guidance documents on all aspects of agreements necessary for Division of Microbiology and Infectious Diseases (DMID) 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 DMID 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 DMID experience in processing CTAs.
  • Assist federal client in developing Memoranda of Understanding (MOU) and Interagency Agreements (IAA) to support Division’s goals.

REQUIREMENTS: The contractor ideally would have:

  • J.D. degree or Bachelor’s degree with 4 to 6 years of experience in clinical research regulatory affairs.
  • Minimum of six (6) 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.

PLEASE APPLY ONLINE

Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.

 
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