Experience:
0-1 years of experience
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Employment Type:
Full time
Posted:
3/9/2018
Job Category:
Research
Industry:
Other
Compensation:
36.00
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IRB Analyst - 1 year contract
Enclipse Corp. | Oakland, California
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Job Description

IRB Analyst

Description:

  • Performs regulatory and/or administrative review and analysis of research study submissions to the Northern California Institutional Review Board for consistency, completeness, and compliance with federal and state regulations and IRB policies and procedures.

  • Acts as point person for questions, and for decision-making and problem-solving for day-to-day IRB operations including the resolution of technical problems and questions of IRB members, researchers and investigators.

  • Communicates with investigators or IRB Committee members to facilitate the review process while incorporating complex scientific and regulatory language and concepts, in addition to relevant ethical concerns, if any.

  • Provides guidance to research coordinators and investigators regarding applications in preparation for submission to NCAL IRB.

Top Daily Responsibilities:

  • Staffs and coordinates the NC IRB by preparing and previewing items on the IRB meeting agendas, attends IRB meetings, records and assists in writing IRB meeting minutes, and follow-up correspondence.

  • Communicates with investigators to facilitate the review process while incorporating complex scientific and regulatory language and concepts.

  • Advise and counsel on matters of general research compliance and ethical human participant research practices.

Requirements:

  • Bachelor's degree preferred, High school diploma required

  • CIP preferred

  • Minimum 1 year experience in research compliance, the protection of human subjects, or equivalent.

  • Minimum of 1 year experience with federal, state, and local regulations related to protection of human subjects and applying ethical principles regarding protection of human subjects or research compliance.

  • Minimum four (4) years of experience working in Microsoft Office suite and Electronic research systems.

  • Has a working knowledge of scientific and medical concepts and terminology.

  • Experience reviewing Exempt and/or Expedited research.

  • Ideal candidates would have experience working in an IRB or regulatory department and providing either regulatory or administrative support to an IRB Committee.

  • Demonstrated strong interpersonal, oral and written communication

  • Comprehension of and ability to problem solve within the framework of federal regulations, laws, and guidance pertaining to human subject protections, including 45 CFR 46, 21CFR50, 56, HIPAA, Good Clinical Practice, the Declaration of Helsinki, and the Belmont Report, and the NCAL IRB Policies and procedures in order to identify issues or concerns that must be addressed in order to approve research study submissions.

  • Ability to manage several projects at once and ability to work under pressure.

Qualifications

Applicants must be eligible to work in the specified location

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