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Clinical Advisor - NIH - DAIDS

Company: CAMRIS International
Location: Bethesda
Posted on: June 6, 2021

Job Description:

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, bio-defense, 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 of the overall functions of the Protections of Particiants, Evaluation and Policy Branch in the Office for Policy in Clinical Research Operations, Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH).

 


  • Develop, draft, and compile policy or procedures documents for the Division of AIDS either independently or as part of a working group. 

  • Provide leadership, editorial expertise, and consultative support to the Division of AIDS through creation of Clinical Research policies and related procedures, as well as DAIDS human subjects clinical research policies, in compliance with all applicable US Federal regulations and international guidelines, such as ICH, and other relevant guidelines. 

  • Provide DAIDS staff advice on the interpretation of human subjects’ protections regulations, protocol compliance in the area of human subject protections, and the additional requirements under 45 CFR 46 Subparts B, C, and D as well as other applicable regulations (21 CFR 50, etc) and guidelines (ICH and others as applicable). 

  • Serve as the subject matter expert, providing expertise on HIV, associated comorbidities (such as TB), etc. needed to evaluate human subject protection issues, and maintain such scientific expertise. 

  • Contribute to the review of individual protocols presented at DAIDS’ Scientific Review Committees, from a human subject protection perspective. 

  • Provide direct human subjects protections support to protocol development teams, clinical operations offices, project specific working groups and other DAIDS and DAIDS’ Stakeholders in their oversight of the implementation of DAIDS’ sponsored and/or funded clinical research. 

  • Provide advice to inform the departmental Branch Chief of activities related to policies; perform project management, and administrative tasks related to development and/or modification of policies and procedures. 

  • Conduct in-depth research for development and/or modification of clinical research policies in a variety of areas (for example, clinical trial conduct and oversight, safety, research participant privacy protections). 

  • Review and edit existing policies and procedures per DAIDS QMS process and timelines. 

  • Provide NIH and NIAID-wide benchmarking, policy research, and analyses in support of DAIDS policy development, management, and/or administration. 

  • Serve as a Content Manager for the internal ProPEP policies and procedures and DAIDS external clinical research policy website. 

  • Develop policy briefings for the departmental Branch Chief, OPCRO leadership and/or other DAIDS’ leadership. 


  • All support positions required a minimum of a BS degree; some require a MS, MD, or Ph.D. 

  • At least 5 years of relevant of experience years in the field of human subject protection and policy development. 

  • The education, skills and relevant years of experience required for each support position are consistent with those identified as the minimum requirements for the labor categories specified in the contract. 

Keywords: CAMRIS International, Bethesda , Clinical Advisor - NIH - DAIDS, Other , Bethesda, Maryland

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