| IRB Administrator -- New York, NY |
Author: Jon Merz
Date: 01-18-12 15:53
General Description:
Office of the Vice Chancellor for Research at The City University of New York (CUNY) is seeking an Institutional Review Board (IRB) Administrator. The Administrator will be responsible for the efficient management of CUNY's five IRBs, which review and approve research involving the participation of human subjects for the nineteen (19) CUNY Colleges. The Administrator holds the primary responsibility for the oversight, administration and management of all IRB business, including the implementation of federal and State regulations and University policies, and for ensuring IRB and institutional compliance.
Duties include:
* Responsible for developing and implementing daily operational procedures for the efficient review of research proposals involving the participation of human subjects
* Conduct preliminary review of all submissions requiring review by a convened IRB.
* Assess the nature of the research and identify the expertise required for an appropriate review to ensure compliance with federal regulations.
* Provide regulatory, ethical and administrative guidance to IRB members, researchers and campus-specific IRB Coordinators.
* 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 campus-specific IRB Coordinators on policies and procedures regarding IRB review of human subjects 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 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 Committee records.
* Oversee the creation of complex meeting minutes, which include detailed description of the Committee deliberations, outline of controverted issues and their resolution, and the justifications and ethical principles analyzed and reviewed by the Committee.
* Collaborate with the Director for Research Compliance in receiving, documenting and ensuring adequate review of investigator, staff and subject complaints regarding the conduct of human subjects research.
* Collaborate with the Director for Research Compliance in performing analysis of and ensuring adequate and timely review of protocol violations, unanticipated events and allegations of non-compliance with applicable regulations and policies brought to the IRB's attention.
* Assist the Director with development and implementation of Human Subjects Research policies.
* Assist the Director for Research Compliance with the implementation of for-cause and not-for-cause human subjects research audits.
* Assist the Director for Research Compliance with the development and implementation of human subjects research education and training plan for CUNY research community.
* Assist the Director for Research Compliance with the development and implementation of quality improvement plan for CUNY's human research protection program.
* Maintaining the IRB database.
* Will be expected to travel to the various CUNY campuses
* Other duties as assigned by the Director.
Salary: Commensurate with experience
Qualifications
* Minimum, Bachelor's degree.
* Experience with federal (OHRP, NIH, FDA and other government agencies) and state regulations governing human subject research.
* Knowledge of principles of ethical conduct of research with human subjects.
* 3-5 years administrative experience in human subjects protections.
* Currently holds or must seek certification as a Certified IRB Professional (CIP) within 36 months of hire.
* Ability to analyze and apply regulations to written research protocols and convey information verbally and in writing to faculty and staff.
* Knowledge of computer application packages and software to track IRB applications (experience with IRBNet is preferred).
* Strong interpersonal and communication skills to work with all levels of individuals in a respectful and supportive manner.
* Ability to handle constant and recurring deadlines.
* Effective time management skills.
Position will remain open until filled.
To apply, please go to rfcuny.org. and click on About RF, then Careers. The position is listed under the Managerial and Professional category. Alternatively, you may click on the following link: http://www.rfcuny.org/hr/pvn/cgi-bin/show_job.asp?pvn=RIS-1324 .
An AA/EO/ADA Employer' (Affirmative Action/Equal Opportunity
Employer/Americans with Disabilities Act) E-Verify Employer
|
|
|
