IRB Specialist

1 month ago

Rockville, Maryland, United States Kelly Full time
Job Title: IRB Specialist

Kelly Government Solutions is a trusted partner to the federal government and its key suppliers. We are seeking a highly skilled IRB Specialist to support the National Institutes of Health (NIH) in Rockville, MD.

About the Role:
  • Prepare regulatory submissions for approval to initiate clinical studies of emerging infectious diseases.
  • Conduct quality control reviews of IRB applications and all forms and documents included in the submission packets.
  • Ensure that advice and actions of VRC/CTP staff are consistent with NIAID, NIH, and DHHS goals and policy, as well as with applicable statutes, regulations, rules, guidance and directives of the NIH IRB.
  • Use information technology/telecommunication systems for document management and document control.
  • Work in conjunction with the research nurse / study coordinator and the monitoring staff to schedule and attend monitoring visits for VRC protocols and to resolve and address findings generated during the visit.
Requirements:
  • Master's degree in Life Sciences or other related discipline. Two (2) years of specialized experience plus a BA/BS degree is equivalent to a master's degree.
  • Minimum of two (2) years of experience in related field. Expertise in the fundamentals of clinical trials.
  • Experience in clinical data and regulatory management and monitoring for clinical studies.
  • Active knowledge of current regulatory and IRB requirements.
What We Offer:
  • Competitive compensation and comprehensive benefit package.
  • Optional health, vision, and dental plans.
  • Paid leave (min 120 hours) as well as 11 paid federal holidays and 401K plan.
  • Access to NIH's unparalleled resources and niche scientific initiatives.

Kelly Government Solutions is an equal opportunity employer and welcomes applications from diverse candidates. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.

  • IRB/Compliance Specialist

    4 weeks ago

    Rockville, Maryland, United States Mid-Atlantic Permanente Medical Group PC Full time

    Job DescriptionMid-Atlantic Permanente Medical Group PC invites applications for an IRB/Compliance Specialist to support the organization's Compliance department and Institutional Review Board (IRB) activities. This is a full-time opportunity that is fully remote, with candidates required to reside in Washington D.C., Maryland, or Virginia, or be willing to...

  • Research Nurse

    1 month ago

    Rockville, Maryland, United States Cape Fox Shared Services Full time

    Job Title: Research NurseCape Fox Shared Services is seeking a highly skilled Research Nurse to join our team in Bethesda, MD. As a Research Nurse, you will play a critical role in supporting the NIH and contributing to the success of our clinical trials.Key Responsibilities:Recruit and screen patients for inclusion in protocols and clinical trials.Assist...

  • IRB/Compliance Specialist

    4 weeks ago

    Rockville, Minnesota, United States MAPMG Full time

    Job Title: IRB/Compliance SpecialistMid-Atlantic Permanente Medical Group (MAPMG) is seeking a highly skilled IRB/Compliance Specialist to join our Legal department. This is a full-time opportunity that is fully remote. Candidates must reside in Washington D.C., Maryland, or Virginia, or be willing to relocate to one of these locations for consideration.As...

  • IRB/Compliance Specialist

    4 weeks ago

    Rockville, United States Mid-Atlantic Permanente Medical Group Full time

    Mid-Atlantic Permanente Medical Group (MAPMG) invites applications for an IRB/Compliance Specialist to join our Legal department. This is a full-time opportunity that is fully remote. Candidates must reside in Washington D.C., Maryland, or Virginia, or be willing to relocate to one of these locations for consideration.Mid-Atlantic Permanente Medical Group is...

  • IRB/Compliance Specialist

    4 weeks ago

    Rockville, Minnesota, United States Mid-Atlantic Permanente Medical Group Full time

    Job SummaryMid-Atlantic Permanente Medical Group is seeking a highly skilled IRB/Compliance Specialist to join our Legal department. This is a full-time opportunity that is fully remote. Candidates must reside in Washington D.C., Maryland, or Virginia, or be willing to relocate to one of these locations for consideration.About UsMid-Atlantic Permanente...

  • Research Nurse

    3 weeks ago

    Rockville, United States Cape Fox Shared Services Full time

    Concentric Methods is seeking a Research Nurse to join our team in Bethesda, MD in support of the NIH. Responsibilities: Recruits and screens patients for inclusion in protocols and clinical trials. Assist research and medical staff interview, screen and evaluate the appropriateness of eligible subjects for participation in the research protocol. Participate...