Clinical Research Coordinator – NIAID – Bethesda, 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 Research Coordinator with the National Institutes of Allergy and Infectious Disease in Bethesda, MD.

This is a long-term contract position which offers:

• Competitive compensation and comprehensive benefit package
  

  • Optional health, vision, and dental plans
    

  • Paid leave (min 120 hours; pro-rated for part time positions) as well as 11 paid federal holidays and 401K plan.  
    

  • Access to NIH’s unparalleled resources and niche scientific initiatives
    

  • Learn more about what Kelly can do for you at https://government.kellyservices.us/
    

TASKS. The contractor shall:

• As a member of the Protocol Operations team, develop clinical research protocols and informed consents for evaluation of investigational vaccines and monoclonal antibodies, including but not limited to the following tasks: conduct background research on infectious diseases targets and any already developed, related countermeasures; review and interpret scientific data and technical information to include in the protocol as background and rationale; take on the primary responsibility of drafting the protocol and informed consent documents in close collaboration with the trial principal investigator (PI) and other members of the clinical research team; ensure compliance with regulatory requirements for clinical research and adherence to established protocol development timelines.
  

• Distribute protocol and study documents to VRC personnel, scientific collaborators, and contractors from Clinical Research Organizations (CROs) per the work instructions of the Protocol Operations team.
  

• Draft protocol amendments, continuing reviews, and other protocol-related documents in close collaboration with the study PI, and with other clinical research team members, that are  submitted to the IRB or FDA and facilitate review of these documents by the clinical research team.
  

• Assist the clinical research team with responses to stipulations from the IRB.
  

• Assist the clinical research team with responses to any correspondence and questions from the FDA related to clinical protocols.
  

• Collaborate with staff of the VRC Regulatory Science and Strategy Program (RSSP) by contributing to the clinical research sections of investigational new drugs (IND) applications, investigational brochures, IND annual reports, and any other submissions to FDA requiring clinical research input.
  

• Ensure that protocol-related data collection plan documents are consistent with regulatory requirements and the protocol objectives.
  

• Gather, interpret, summarize, and/or graph clinical research research data included in protocols, IND applications, IND annual reports, investigator brochures or that are submitted for reporting to clinicaltrials.gov.
  

• Assist with tracking the workflow of the Protocol Operations team to ensure timely development, completion, and submission of protocols and of all protocol-related documents.
  

• Assist in processes for quality assurance and quality control of protocol and protocol- related documents, including at the time of their submission to the IRB.
  

• Develop, update, and review work instructions (WIs) and standard operating procedures (SOPs) for the Protocol Operations team and implement contributions to and review of these documents by other team members of the Protocol Operations team.
  

• Contribute to the development of Data Collection Forms (DCFs), electronic case report forms (eCRFs), and Reliance Agreements
  

• Practice and facilitate adherence to SOPs, Good Clinical Practice (GCP), and Food and Drug Administration (FDA) regulations.
  

• Demonstrate strong communication and collaboration skills with the Protocol Operations team and with other teams in the CTP or outside of the CTP

REQUIREMENTS. The contractor must have:

• Ph.D. and/or M.D. with at least one year experience in clinical research or in a related field. Master’s degree with at least 3 years of experience in clinical research or in a related field.
  

• Prior experience managing a team preferred

PLEASE APPLY ONLINE
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 part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, short-term disability, and a transportation spending account.
Visit https://www.mykelly.us/us-mykelly/perks/ for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
 

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