Experience:
No experience
Employment Type:
Full time
Posted:
1/26/2018
Job Category:
Research
Industry:
Other
Compensation:
36.00
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IRB Specialist - 6 month contract
Enclipse Corp. | Oakland, California
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Job Description

IRB SPECIALIST

Description:

  • Manages regulatory aspects of small to large-scale research projects.

  • Supervises and assists IRB staff.

  • Works independently in accordance with established objectives.

  • Identify issues or concerns that must be addressed in order to approve the research under the expedited procedure. 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 internal IRB Policies and procedures.

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

  • Communicates with investigators 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 internal IRB.

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

Top Daily Responsibilities:

  • Identify issues or concerns that must be addressed in order to approve the research under the expedited procedure.

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

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

Requirements:

  • Bachelor's degree preferred (If no, can be substituted with 2 additional years of experience), High school diploma required

  • Minimum four (4) years in clinical research or clinical trials, clinical research compliance, the protection of human subjects, or equivalent. (Six years if no bachelor's degree)

  • Minimum four (4) years of experience with federal, state, and local regulations related to protection of human subjects and applying ethical principles regarding protection of human subjects. (Six years if no bachelor's degree)

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

Qualifications

Applicants must be eligible to work in the specified location

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