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    Human Subjects Research Protection Specialist (Clinical Research) - NIH - Rockville, MD

    Kelly Services

    , Rockville, MD 20852
    Full-time, Part-time

      Human Subjects Research Protection Specialist (Clinical Research) - NIH - Rockville, MD

      Kelly Services
      Rockville, MD 20852
      Full-time, Part-time
      Refer friends, get paid!

      Job Description

      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 the leading medical research center in the world.  We are seeking an experienced individual to work as a Human Subjects Research Projection Specialist (Clinical Research Advisor) at the National Institutes of Health in Rockville, MD.
      This is a long-term contract position which offers:
      - Competitive compensation and comprehensive benefit package
      - Optional health, vision, and dental plans
      - Vacation leave as well as 10 paid federal holidays and 401K plan.  
      - Access to NIH’s unparalleled resources and niche scientific initiatives

      TASKS/SERVICES. The contractor shall: 
      (1) Develop, draft, and compile policy or procedures documents either independently or as part of a working group in support of the overall functions of the Protections of Participants, Evaluation and Policy Branch (ProPEP) in the Division of AIDS (DAIDS) 
      (2) 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. 
      (3) 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). 
      (4) 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. 
      (5) Contribute to the review of individual protocols presented at DAIDS’ Scientific Review Committees, from a human subject protection perspective. 
      (6) 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. 
      (7) Provide advice and develop policy briefings to inform the departmental Branch Chief and leadership of activities related to policies; perform project management, and administrative tasks related to development and/or modification of policies and procedures. 
      (8) 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). 
      (9) Provide NIH and NIAID-wide benchmarking, policy research, and analyses in support of DAIDS policy development, management, and/or administration. 
      (10) Serve as a content manager for the internal (ProPEP) policies and procedures and DAIDS external clinical research policy website. 

      REQUIREMENTS. The contractor must have at least: 
      (1) Bachelor’s degree in Biology, Public Health, Nursing, or a related discipline.  Advanced degree (Master’s or Ph.D.) in relevant field preferred.
      (2) Minimum of 5 years of relevant experience in the field of human subject protection and policy development. 
      (3) Experience with clinical research protocols and operations along with knowledge of federal regulations and guidelines 

      When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time. 

      Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t contacted for this position, you are still part of our talent network.  All Kelly recruiters have access to your profile, which expands your opportunities even further.

      As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients.  We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise.  With a focus on safety, value, well-being, investment, and opportunity, Kelly’s Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what’s next.

      It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.

      Why Kelly®?

      Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly® Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. It's just another way we make the job search work for you.

      About Kelly®

      Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We're always thinking about what's next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.

      Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law.

      Posting ID: 600637986Posted: 2021-01-27