Clinical Advisor - NIH - DAIDS/OPCRO

Job Locations US-MD-Bethesda
# of Openings
1
Category
NIAID
Type
Regular Full-Time

Overview

CAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.

 

CAMRIS attracts the next generation of scientists to work at premier government research and development institutions with state-of-the-art facilities and equipment, under world leaders in health research. Our exceptional benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, and life insurance. If you enjoy being a part of a high performing health and research organization dedicated to making the world a healthier place, please apply today!

 

We are seeking a Clinical Advisor to support the overall functions of the Clinical Trials Agreemenst Team in the Office for Policy in Clinical Research Operations, Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID)., NIH: 

 

Responsibilities

  • 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

Qualifications

  • J.D. degree or advanced degree in a biological field (M.S. or Ph.D.).
  • Minimum of three (3) years of clinical research regulatory affairs experience.
  • Experience negotiating clinical trials agreements is required

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