IRB/Regulatory Specialist

Silver Spring, MD
Jun 22, 2021
Jul 02, 2021
Finance, Other
Full Time
Job Summary/Company:

Sparks Group in partnership with a leading health system, is searching for a skilled and qualified IRB/Regulatory Specialist. An internationally recognized pioneer, with multiple specialized health centers, the client is seeking a Specialist who will be responsible for providing administrative and regulatory support to the organizations IRBs in the review and oversight of research involving human subjects. If you are looking for a new opportunity that helps you enhance your skill set, apply now!

  • Manage multiple priorities and a high-volume workload: coordinates, monitor, and provide regulatory compliance assistance to Institutional Review Board (IRB) and or IRB Chair
  • Draft, assemble and review all required documents pertaining to reliance situations and check for accuracy
  • Prepare technical documents regarding compliance with federal requirements; conduct audit for IRB panel
  • Propose recommendations for the IRB review in accordance with federal and institutional codes, rules, and regulations governing research
  • Provides assistance to investigators regarding the procedural requirements of complex IRB applications
  • Generate compliance pre-review; develop meeting agenda, supplemental materials and documents
  • Support the development, revision, and maintenance of IRB policies, guidance, and education/training documents
  • Ensure that all operational priorities are aligned with the mission and direction of IRB

Qualifications/Background Profile:
  • Bachelor's Degree in a related field required; Master's Degree preferred
  • Prior experience working with the IRB Office accepted in lieu of a degree
  • 3+ years of experience in IRB/Research administration required
  • Certified IRB Professional certification desired; or the ability to obtain one
  • Knowledge of scientific and medical terminology; ability to analyses research protocol
  • Familiarity with federal and state laws, regulations, and policies to protect human subjects
  • Solid communication skills with the ability to communicate with teams or present recommendations to increase the efficiency of the processes
  • Demonstrated ability to make technical presentations to expert audience and handle confidential information
  • Proficient in using Microsoft Office applications; intermediate to advanced Excel skills

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Qualified candidates should send their resume AND call Sparks Group for additional details. Please note, resume must include a valid email address in order to be considered. We look forward to discussing your background, your current job search, and your potential career path with Sparks Group!

Sparks Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, pregnancy, citizenship, family status, genetic information, disability, or protect veteran status.

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