PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
Responsible for preliminary review and processing of new IRB applications and other submissions, facilitation of ancillary reviews, generating and maintaining IRB agendas, preparation and publication of IRB letters, creating minutes, and managing other IRB records.
Serve as an IRB member to review, deliberate, vote on the approval of research protocols, and recommend necessary modifications to protocols. Carry out delegated responsibilities of the IRB Chair, including making Exempt, Not-Research, and Not-Engaged determinations.
Serve as subject matter expertise in human research protections to provide support and client service to IRB members, investigators, and the research community to ensure regulatory compliance and research integrity, assist with AAHRPP accreditation and/or GAP analysis, assisting with evaluation and implementation of new IRB software and associated policies and processes. Carry out process improvement activities, training of IRB members, Investigators, and staff. Provides input to enhance IRB website. Facilitate and assist with monitoring, audits, and other compliance activities.
Facilitate review and execution of IRB related agreements: DUA, BAA, MTA, Confidentiality and Non-Disclosure Agreements, IRB Reliance Agreements, and Individual Investigator Agreements.
Manage reliance of external or local IRB for multi-site institutions, including confirmation of applicable local research context for Single IRB (sIRB) review.
Assist with the administrative implementation and development of an interprofessional central scientific review committee (icSRC) and assist with processing projects for the icSRC.
Other related duties to be assigned as needed, including other duties within the SUNY Research Foundation.
Scheduled Days/ Hours: 9 AM to 5 PM, flexible.
Temporary remote work from other locations available during the pandemic.
As an Equal Opportunity / Affirmative Action Employer, The Research Foundation for SUNY will not discriminate in its employment practices due to an applicant's race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), sexual orientation, gender identity or expression, transgender status, age, national origin, marital status, citizenship, physical and mental disability, criminal record, genetic information, predisposition or carrier status, status with respect to receiving public assistance, domestic violence victim status, a disabled, special, recently separated, active duty wartime, campaign badge, Armed Forces service medal veteran, or any other characteristics protected under applicable law.
2-year experience with an IRB, clinical research, or human research compliance.
Broad knowledge of Federal and State regulations and guidelines, including but not limited to FDA, Common Rule, and HIPAA.
Excellent time management skills.
Demonstrated skills in providing excellent customer service.
Demonstrated strong interpersonal, verbal, and written communication skills.
Demonstrated knowledge and understanding of the IRB process.
Ability to respect strict confidentiality.
Solid computing skills: word processing, spreadsheets
Bachelor's, Master’s, or PhD degree in health sciences or a related field or MD.
Familiarity with International human research regulations and privacy laws.
Working knowledge of scientific and medical concepts and terminology.
Knowledge of AAHRPP accreditation standards.
Knowledge of local Downstate policies pertaining to human research.
Telecommuting is allowed.
Internal Number: P08212020
About SUNY DOWNSTATE HEALTH SCIENCES UNIVERSITY
This position is within the Office of Research Administration at The Research Foundation for The State University of New York at Downstate and supports the SUNY Downstate Health Sciences University Institutional Review Board & Privacy Board. The Downstate IRB delivers high quality, focused, efficient, and friendly service to Downstate investigators and fosters an environment which facilitates collaboration with external investigators. The Downstate IRB supports investigators from University Hospital SUNY Downstate, the Colleges and Schools of SUNY Downstate Health Sciences University, NYC Health+Hospitals/Kings County, University Physicians of Brooklyn, and other sites, including private companies who are tenants of the Downstate Incubator. Downstate is experiencing significant opportunities for research: from the basic sciences; to translational investigation; to clinical trials; to population research and health equity and disparities research; to health information technology; to evidence-based research in nursing. Many of our investigators collaborate with international sites.
The Downstate IRB successfully responded to the COVID-19 health emergency and the disruptions ...it created with the research enterprise, including implementation of new guidance, a Rapid Response IRB for COVID-19 clinical trials, and remote research operations. During the height of the pandemic in Brooklyn, Downstate experienced a 325% increase in full board submissions, a 32% increase in expedited review submissions, and a 72% increase in exempt submissions. The IRB continues to provide a critical service during this health emergency and while ramping up the research.