Senior Research Compliance Administrator

Overview

The Office of Research at The City University of New York (CUNY) is seeking a Senior Research Compliance Administrator. Reporting to the Associate Vice Chancellor for Research, the Administrator serves the University in various capacities: 50% as an Institutional Review Board (IRB) Administrator; 25% as the Conflicts Committee Administrator; and 25% policy and procedure development, and implementation of education and quality improvement programs for all areas of research compliance for the twenty-five (25) CUNY colleges and schools. These compliance areas include human subject protection, animal care and use, responsible conduct of research, including research misconduct, conflict of interest, biosafety and export control. The Senior Research Compliance Administrator will also lead efforts toward identifying, developing and implementing an electronic management system for various research compliance functional areas. The incumbent also supervises one Research Compliance Analyst.

Duties include:

IRB Administrator – 50%

• Responsible for developing and implementing policies and procedures for the efficient review of research proposals involving the participation of human subjects.

• Conduct preliminary review of submissions requiring review by a convened IRB.

• Assess the nature of the research and identify expertise required for an appropriate review to ensure compliance with federal regulations, state laws & CUNY policies.

• Provide regulatory, policy and administrative guidance to IRB members, researchers and college-based HRPP Coordinators.

• Compose detailed and highly complex correspondence that adequately reflect all IRB concerns, provide the rationale for their concerns, and provide regulatory and ethical education, in a concise and intelligible manner.

• Participate in the cross training of college-based HRPP Coordinators on policies and procedures regarding HRPP/IRB review of human subject research.

• Identify and recruit external consultants, auditors, and other experts as required by the IRB, and maintain effective communications with all third parties.

• Oversee IRB meeting schedules to ensure the presence of a quorum; oversee preparation of material for IRB meetings to ensure that all relevant documents are provided and that applications are ready for IRB review; develop meeting agendas and maintain confidentiality of IRB records.

• Oversee the creation of complex meeting minutes, which include detailed description of IRB deliberations, outline of controverted issues and their resolution, and the justifications and ethical principles analyzed and reviewed by the IRB. 

• In collaboration with the other members of the research compliance team, receive, document and ensure adequate review of investigator, staff and subject complaints regarding the conduct of human subjects research.

• In collaboration with the other members of the research compliance team, perform analysis of and ensure adequate and timely review of protocol violations, unanticipated events and allegations of non-compliance with applicable regulations and policies brought to the HRPP’s attention.

• Maintain the IRB database.

Conflicts Committee Administrator – 25%

• Assists the Associate Vice Chancellor for Research in developing conflict of interest procedures.

• Responsible for developing and implementing operational procedures for the efficient review of conflict of interest in research.

• Conduct preliminary review of cases requiring review by the Conflicts Committee.

• Provide regulatory, policy and administrative guidance to Conflicts Committee members, researchers and College Conflicts Officers.

• Compose detailed and highly complex correspondence that adequately reflect all Committee concerns, provide the rationale for their concerns, and provide regulatory and ethical education, in a concise and intelligible manner.

• Participate in the cross training of College Conflicts Officers on policies and procedures regarding conflicts of interest in research.

• Oversee Committee meeting schedules to ensure the presence of a quorum; oversee preparation of material for Committee meetings to ensure that all relevant documents are provided and that applications are ready for Committee review; develop meeting agendas and maintain confidentiality of records.

• Oversee the creation of complex meeting minutes, which include detailed description of Committee deliberations and determinations. 

Policy, Education & QA/QI – 25%

• Assist in the development and implementation of research compliance policies and procedures.

• Assist in the implementation of research compliance education and training initiatives.

• Assist with the implementation of research compliance QA/QI initiatives.

Cross-Functional Responsibilities

• Assist in the identification, development and implementation of electronic management system for various research compliance functions

• Expected to travel to the various CUNY campuses

• Other duties as assigned by the Associate Vice Chancellor for Research.

Core Competencies / Qualifications

• Bachelor’s degree required; Master’s degree preferred

• Knowledge of principles of responsible conduct of research
• Experience with federal and state regulations governing human subject research,  preferred experience also in conflict of interest in research and biosafety
• 3-5 years of experience in supporting systematic research compliance programs in a university setting
• Ability to analyze and apply regulations to written research protocols and convey information verbally and in writing to faculty and staff
• Strong interpersonal and communication skills
• Ability to handle constant and recurring deadlines
• Effective organization and time management skills