Location: Binghamton, NY Category: Professional Posted On: Fri May 3 2019 Job Description:
Budget Title: Staff Associate (SL-4)
The Office of Institutional Review Board for the Protection of Human Subjects (IRB) assures regulatory compliance pertaining to human subjects research. The IRB Associate Director at Binghamton University, State University of New York reports directly to the Assistant Vice President for Research Compliance and is responsible for providing the necessary oversight ensuring that the routine operations of the IRB and the review of the protocols are conducted in an efficient, effective and compliant manner.
The duties of the IRB Associate Director include but are not limited to:
Provides consultation to the Institutional Review Committee (IRB) Chair, IRB, Institutional Official (IO), administrators, researchers, and other research stakeholders on complex research issues related to human subjects including application of DHHS, FDA and other applicable regulations and statutes for the protection of human subjects to specific research situations
Resolves questions or conflicts and provides clarifications regarding regulatory or policy matters related to the IRB
Serves as a voting member of the IRB and responsible for the oversight of administrative reviews of exempt research and in conducting minimal risk expedited protocol review
Facilitates single IRB as needed; collaborates with multiple stakeholders and external IRBs to maximize efficiency while improving human subject protection to facilitate multi-regional and collaborative research
Oversight of the Post Approval Monitoring program
Assists the Chair and IRB Coordinator in the facilitation of the IRB meetings and proceedings. Contributes to and reviews IRB meeting minutes to ensure they are accurate and processed in a timely manner and in meeting regulatory requirements
Prepares an annual evaluation of IRB Chair and members to the IO for re-appointments
Oversight of web-based system(s) for regulatory agency communication to revise and renew the Binghamton University FWA, IRB, and IORG as reported to OHRP to remain current and accurate
Provide departmental contact with regulatory agencies, as needed
Monitors and analyzes new legislation, federal regulations, guidance documents, and program initiatives to keep abreast of current trends and changes in the research community and implement effective strategies of dissemination to ensure compliance, including drafting, updating, and monitoring Standard Operating Procedures (SOPs)
Conducts outreach and educational/training activities
Continually assess efficiency and effectiveness of internal policies and processes for the review of protocol submissions to inform decisions regarding operational procedural effectiveness and improvement opportunities
Recommends policy and/or procedural changes to the Assistant Vice President for Research Compliance as appropriate and in accordance with office Standard Operating Procedures (SOPs)
Initiates special projects designed to enhance office procedures, IRB performance, or overall human subject protections
In coordination with the IRB Coordinator, maintain the IRB website
Responsible for maintaining AAHRPP accreditation including annual reporting
Prepares annual reports for the Division Administration
Coordinates with Sponsored Programs ensuring human subjects research protocols are approved prior to the release of funds for such activity
Advises the IO of unanticipated problems involving risks to human subjects or others and alleged and documented serious and/or continuing non-compliance
Identifies and communicates to the Assistant Vice President for Research Compliance and research compliance staff correlative compliance related research activities to ensure coordinated compliance oversight is achieved
Liaison with other departments at a high level
Collaboration with Division of Research staff and administration to ensure an integrated compliance effort
Three (3) to five (5) years of significant IRB and/or Human Subjects research experience
Demonstrable professional demeanor and ability to work independently and as a member of the team collaborating with partners in research from a wide range of constituencies
Demonstrated excellent written, verbal, and interpersonal communication skills; attention to detail; and organizational and prioritization skills to address a variety of projects simultaneously
Strong computer skills and competencies in Microsoft Office
Experience in the implementation of education and training initiatives, and assessment activities
In depth knowledge of federal, state and local laws and regulations and industry requirements and practices (e.g. Revised Common Rule, FDA, IND/IDE, Clinical Trails.gov, state regulations) on the proper conduct of human subject research
Extensive experience in reviewing and processing social science, public health, behavioral and biomedical human subjects research
Experience with IRB online systems administrative management
Experience working in a university setting
Experience communicating with ethnically and culturally diverse populations and matters pertaining to staff and committee minority recruitment and retention
Ability to follow all university policies, procedures, and guidelines including but not limited to safety, civility, information security, and non-discrimination policies and procedures
Certification as an IRB professional (CIP). It is anticipated that the individual in the role will hold a CIP within two years of hire
Offers of employment may be contingent upon successful completion of a pre-employment background check and verification of degree(s) and credentials.
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Equal Opportunity/Affirmative Action Employer The State University of New York is an Equal Opportunity/Affirmative Action Employer. It is the policy of Binghamton University to provide for and promote equal opportunity employment, compensation, and other terms and conditions of employment without discrimination on the basis of age, race, color, religion, disability, national origin, gender identity or expression, sexual orientation, veteran or military service member status, marital status, domestic violence victim status, genetic predisposition or carrier status, or arrest and/or criminal conviction record unless based upon a bona fide occupational qualification or other exception.
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Internal Number: 110089
About Binghamton University
Binghamton University is a world-class institution that unites more than 130 broadly interdisciplinary educational programs with some of the most vibrant research in the nation. Our unique character — shaped by outstanding academics, facilities and community life — promotes extraordinary student success.
Binghamton merges rigorous academics, distinguished faculty and state-of-the-art facilities to engage and challenge its 17,000 students. The high-achieving Binghamton student body also represents a great diversity of life experiences, from first-generation college-goers to international students. Beyond their talent, these classmates share a desire to shape the future through technology, insight, intellectual exploration and community service.