IRB Compliance Specialist — Remote

nki; Orangeburg (NY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Nathan Kline Institute (NKI) is seeking an IRB Coordinator to support the Human Research Protection Program, maintain IRB files, and educate research teams on ethical conduct and regulatory requirements. The role involves pre-review, HRPP policy work, and coordinating IRB meetings in a fast-paced research setting.

The position allows up to 50% remote work and requires strong communication, adherence to federal guidelines, and the ability to interface with FDA-compliant research projects under

Qualifications

• BA or BS or equivalent background and experience, preferably in life, physical or social science.
• At least 1 year IRB staff experience.
• Working knowledge of ethical principles and regulatory information regarding the protection of human research participants (DHHS and FDA).
• Understanding of the operational requirements related to the management and implementation of the IRB review process.
• Demonstrated excellent oral and written communication, problem solving and analytical skills necessary to quickly identify and synthesize salient features from a fast-paced discussion of highly technical broad-ranging information into a cohesive and well-written correspondence to researchers and other audiences.
• Excellent interpersonal skills, political acumen and tact needed to work with a wide variety of customers, including faculty members, research staff, students, IRB members and Chair persons, with colleagues and managers, and with external parties such as government officials in a consistently professional and service-oriented manner.
• Ability to work with an electronic IRB review system; guide or provide assistance to others using the system for IRB submission, review and approval.
• Ability to maintain strict standards of confidentiality in dealing with protected information.

Responsibilities

• Conduct pre-review of human subjects research submissions, not human subjects research, reliance, and QI/QA projects and prepare materials for primary reviewers.
• Facilitate full IRB review per HRPP policies, state law, and federal regulations.
• Attend and participate in IRB Committee meetings.
• Ensure research requests are compliant with all applicable institutional policy, state laws and federal regulations.
• Determine IRB requirements of approval are met for human subjects research requests.
• Maintain clear and accurate IRB files both electronic and hard copies.
• Provide support and guidance to investigators from initial proposal review and submission through completion of the study. Serve as liaison between IRB and investigators.
• Assist in the development or revision of HRPP policies, procedures, forms, and checklists as necessary.
• Participate in on-line training, webinars, and in-person education as required by the HRPP.
• Prepare and modify documents including correspondence, reports, drafts, memos, and emails.
• Prepare agendas for meetings and distribute minutes of meetings.
• Maintenance of the NKI education requirements for all research.
• Prepare IRB Meeting Minutes
• Other duties as assigned by the supervisor

Skills

Ethical principles & regs knowledge

IRB staff experience

Oral & written communication

Analytical problem-solving

Interpersonal skills

Confidential handling

Electronic IRB systems experience

Education

BA/BS or equivalent

Job description

Nathan Kline Institute (NKI) is seeking an IRB Coordinator to support the Human Research Protection Program, maintain IRB files, and educate research teams on ethical conduct and regulatory requirements. The role involves pre-review, HRPP policy work, and coordinating IRB meetings in a fast-paced research setting.

The position allows up to 50% remote work and requires strong communication, adherence to federal guidelines, and the ability to interface with FDA-compliant research projects under