Regulatory Compliance Manager
Allen Institute for Brain Science - Seattle, WA

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The Allen Institute for Brain Science, located in Seattle WA, is comprised of a multidisciplinary staff committed to understanding how the brain works and helping to unlock the mysteries of neurological diseases and disorders affecting millions worldwide. Serving the scientific community is at the center of our mission to accelerate progress toward understanding the brain and neurological systems. Creating tools and data that advance the pursuits of thousands and thousands of scientists around the world is our contribution to revolutionary neuroscience. To this end, the Allen Institute's resources - each a groundbreaking creation - are free and publicly available online.

This position is responsible for Federal and State Research Regulatory Compliance (governing among other things human, stem cell and animal subject research), Export Controls, Responsible Conduct of Research, and Conflict of Interest, as well as acting as the Human Protections Administrator and be responsible for the day-to-day administration and management oversight for the Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), and the Institute Stem Cell Research Oversight (ISCRO) Committee. The Regulatory Compliance Manager works closely with Environmental Health and Safety to ensure compliance with applicable regulations.

Responsibilities:
Manages, guides and oversees the activities of the Allen Institute research regulatory committees to ensure compliance with Federal and State regulations and assists the committee chairpersons as needed

Guides and provides strategic direction and support to the Institutional Official for the IACUC and the Chairs of the IACUC, IBC and ISCRO in preparation of reports to oversight agencies, renewals of assurances and communications with accrediting organizations, as required

Ensures compliance with export regulations; creates policy and process as needed

Provides broad direction and coordinates research regulatory activities to ensure consistency and enable compliant research

In coordination with the General Counsel, advises staff on regulatory requirements related to research

Coordinates with Facilities Manager to ensure compliance with OSHA and other applicable regulations; assists with the creation of appropriate policies and processes

Designs and implements training programs, and oversees implementation and maintenance of an electronic based record system for Institute research regulatory committees, with the aim of coordinating committee transparency and emphasizing inter-committee cross-functional communication

Establishes and manages an Allen Institute training program for regulatory matters, coordinating or conducting workshops and seminars on the use of human subjects in research, animals in research, recombinant DNA, viral vectors and select agents in research, export regulations, conflicts of interest and the responsible conduct of research

Assists in the development of, and responsible for implementation of, organizational-wide policies and procedures along with strategic plans and objectives relating to regulatory compliance

Manages, guides and oversees the Allen Institute’s policies and procedures relating to conflicts of interest, responsible conduct of research, and export control; manages the Allen Institute’s Conflict of Interest reporting program

Reviews and keeps apprised of changes in regulations to determine potential impact on organization activities

Assists in risk mitigation efforts to reduce financial and legal liability for the organization

Qualifications:
Bachelor’s degree (B.A. or B.S.) from a four year College or university and five years related experience and/or training

Working level of understanding of operational requirements related to the management and implementation of an IRB, IACUC, IBC and ISCRO, preferably in a nonprofit setting

Working level of knowledge regarding Federal and State research regulations, including knowledge of regulations applicable to use of human or animal subjects, use of rDNA, use of stem cells in research, export control regulations and guidance for responsible conduct of research

Understanding of Federal and State health and safety regulations and recordkeeping requirements

Excellent organizational skills and independent decision-making ability

Strong client service attitude

Ability to read, analyze, and interpret the most complex documents

Ability to respond effectively to the most sensitive inquiries or complaints

Ability to write reports, complex papers, speeches and articles using original or innovative techniques or style

Ability to make effective and persuasive speeches and presentations on controversial or complex topics to senior management and/or external groups

Excellent influence management and collaborative interpersonal and communication skills

We offer competitive pay, a generous benefits package, and a dynamic, intellectually challenging environment.

Link to job posting: http://ch.tbe.taleo.net/CH11/ats/careers/requisition.jsp?org=ALLENINSTITUTE&cws=1&rid=317

The Allen Institute for Brain Science is an equal opportunity employer.

Allen Institute for Brain Science - 19 months ago - save job - block
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