Sr. IRB Reliance Manager (Research Compliance Manager 2)

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POST DATE 8/31/2016
END DATE 10/31/2016

Stanford University Stanford, CA

Company
Stanford University
Job Classification
Full Time
Company Ref #
870041
AJE Ref #
576031054
Location
Stanford, CA
Job Type
Regular

JOB DESCRIPTION

APPLY
Stanford University

Sr. IRB Reliance Manager (Research Compliance Manager 2)

Job Number: 72237

We are looking for a bright, intellectually curious individual who is self-driven and highly organized to join the Stanford University-- one of the world's leading research universities--Human Research Protection Program (HRPP) as the Sr. IRB Reliance Manager (Research Compliance Manager 2) within the Research Compliance Office (RCO). RCO's mission is to ensure that Stanford conducts its human research activities in compliance with a complex web of regulatory requirements and with integrity.

Core Duties:

Under the general direction of the HRPP Associate Director for Program Development, the Sr. IRB Reliance Manager is tasked with (1) managing the IRB reliance review process and (2) monitoring the compliance of these studies. Responsibilities include:
Develop, implement, and manage efficient procedures to facilitate the processing of reliance agreements and single IRB (sIRB) reviews, in accordance with Stanford, federal, and state policies and procedures.
Serve as the primary point of contact and expert liaison for IRB Reliance Agreements and single IRB (sIRB) review. Review complex protocol, including identifying problems and issues.
Develop and implement training/educational materials for researchers and HRPP.
Apply knowledge of federal, state, and local regulations, as well as university policies and practices, to ensure compliance with IRB Reliance Agreements; guide or perform monitoring activities; provide assistance in various quality assurance projects.
Lead special projects or meetings and participate in multi-functional teams.

* - Other duties may also be assigned Education & Experience:

Bachelor's degree and five years of relevant experience, or combination of education and relevant experience.

Knowledge, Skills and Abilities:

Comprehensive knowledge of regulatory information regarding the use of human participation in research and teaching.
Demonstrated understanding of the principles of human research protection standards.
Familiarity with grants and contracts functions.
Significant working knowledge of research procedures and terminology, medical terminology, clinical trials, and research data management.
In-depth understanding of operational requirements pertaining to management and implementation of protocol process.
Demonstrated strong verbal and written communication skills.
Advanced knowledge of human subjects protection regulations and best practices
Knowledge of medical/scientific areas, such as gene transfer, HIV AIDS, stem cells, cellular biology, biosafety, health and safety, and epidemiology.
Direct IRB experience with an accredited institution preferred.

Certifications and Licenses:

Ability to obtain or retain Institutional Review Board professional certification.

PHYSICAL REQUIREMENTS*:

Frequently perform desk based computer tasks, seated work and use light/ fine grasping.
Occasionally stand, walk, and write by hand, lift, carry, push pull objects that weigh up to 10 pounds.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

May work extended or non-standard hours based on project or business needs. Occasional cross campus and local travel may be required. May be exposed to allergens, biohazards, chemicals, radiation or electromagnetic fields.

WORK STANDARDS:

Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu/.

Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.

Job: Compliance Legal

Location: Dean of Research

Schedule: Full-time

Classification Level:

To be considered for this position please visit our web site and apply on line at the following link: http://apptrkr.com/870041

Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.

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