Compliance Specialist 4 (Institutional Review Board Analyst)

penn-state-university

College of Medicine

2d ago

CURRENT EMPLOYEES OR STUDENTS :

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JOB DESCRIPTION AND POSITION REQUIREMENTS :

The Human Research Protection Program at The Pennsylvania State University is seeking a Institutional Review Board (IRB) Analyst.

The Analyst will report to an Assistant Director in the Human Research Protection Program and work in collaboration with IRB Analysts, the IRB Director, and the IRB committee.

This individual’s primary responsibility will be to review human research protocols for compliance with governmental regulations and University policy, initiate clear and accurate written correspondence and / or telephone contact with investigators and staff, and request clarification and / or additional information to enable sound judgments to ensure compliance.

They will maintain appropriate documentation of compliance reviews and determinations as required by federal regulations and by University policy

The individual will assist faculty, students and staff in preparing human research protocols for compliance certification, develop and maintain IRB training materials, present seminars / workshops at University Park, the College of Medicine, and other campus locations to faculty, staff and students about regulations and policies governing human participants involved in research at Penn State, and review, prepare, and facilitate agreements for IRB reliance

The Analyst will interact with other University compliance committees and various other offices such as the Office for Research Protections, Office of Sponsored Programs, Office of General Counsel, Office of Information Security, and faculty, staff, and students of all Penn State campuses

The Analyst will collaborate in writing, periodically reviewing and updating IRB policies and guidelines, standard operating procedures, and submission forms

This position will work remotely with limited on campus meetings or in-person educational events

Requires a Bachelor’s Degree or higher plus 6+ years of experience with research or research-related activities or an equivalent combination of education and experience.

Proficiency with Microsoft Office is required and knowledge of and experience with electronic data management systems is strongly desired.

Ability to work efficiently in a complex regulatory environment is critical. This includes excellent interpersonal and communication skills.

Individual must have the ability to manage multiple simultaneous projects with meticulous attention to detail. This individual must be able to work effectively with minimal supervision and demonstrate significant autonomy and judgment with the ability to multi-task and independently reprioritize work to ensure work is completed on time.

CIP (Certified IRB Professional) credential required within one year of eligibility. Individuals with knowledge of federal regulations and professional standards regarding the protection of human research participants or experience in conducting human research are preferred and strongly encouraged to apply.

The Pennsylvania State University is committed to and accountable for advancing diversity, equity, and inclusion in all of its forms.

We embrace individual uniqueness, foster a culture of inclusion that supports both broad and specific diversity initiatives, leverage the educational and institutional benefits of diversity, and engage all individuals to help them thrive.

We value inclusion as a core strength and an essential element of our public service mission.

CAMPUS SECURITY CRIME STATISTICS :

Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act and the Pennsylvania Act of 1988, Penn State publishes a combined Annual Security and Annual Fire Safety Report (ASR).

The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters.

The ASR is available for review .

Employment with the University will require successful completion of background check(s) in accordance with University policies.

Penn State is an equal opportunity, affirmative action employe

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