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Regulatory & Data Specialist

Weill Medical College of Cornell University

New York, NY
Job Code:
Weill Medical College of Cornell University
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Job Details

Job Title Regulatory & Data Specialist

JobID 170

Location: New York, NY

Description Position Summary
Under direction of Institutional Review Board .IRB. Regulatory Supervisors and the Director of the Human Research Protections Program .HRPP., perform tasks as assigned to support the administration of the WCMC IRBs. This individual demonstrates competency in reviewing and processing all IRB submissions independently, including higher level scientific and/or regulatory concerns. Will act as a liaison to other committees and Boards to provide knowledge about IRB regulatory issues. Will represent the IRB with ITS with the ongoing improvement of the existing online system .eIRB. and implementation of the new system .InfoEd.. Able to assist and advise investigators and research coordinators in their preparation of IRB submissions WCMC policies and procedures with minimal assistance.
Job Responsibilities
+ Performs data management activities; maintains/ updates computerized database; creates forms/templates and mail merges; conducts database searches; creates reports. Maintains confidential research files, electronic review guides, protocols & general files.

+ Processes all full Board and/or expedited submission types; pre.reviews to ensure completeness, including accuracy of the information within the protocol, determination of ancillary review and supporting documentation.

+ Prepares agenda; attends IRB meetings; generates correspondence based on the review guides provided by the IRB reviewer and the meeting discussion.

+ Prepares meeting minutes based on the meeting discussion and IRB reviews. Ensures that all WCMC administrative requirements are complete before processing the final approval of the submission.

+ As the subject matter expert, responsible for reviewing expedited IRB submissions including administrative amendments, directed change requests, and continuing reviews that are in data analysis only. Additionally, assists with exemption determinations.

+ Performs expanded reviews of protocols to identify scientific and/or regulatory concerns along with administrative errors, to ensure issues are corrected prior to member review.

+ Works with other committees/departments as a liaison IRB regulatory compliance questions. As the subject matter expert, will provide these committees/departments with regulatory knowledge related to human subjects research.

+ Represent the IRB with WCMC ITS and the initiation of new/existing ITS systems for electronic IRB submissions. Serves as the primary contact for developing and establishing eIRB/InfoEd workflow and process for release to the research community.

+ Assist with functional specifications for eIRB and InfoEd. Work with IT to resolve technical issues experienced by both the research community and the IRB staff.

+ Assist researchers in preparing IRB protocol, including answering questions regarding submission procedures, assistance in navigating the online the IRB protocol application process and assistance in responding to issues raised in the IRB review.

+ Answers and screens telephone calls; responds to general inquiries, including, but not limited to general information to investigators regarding the status of IRB protocols; disseminates information regarding Board deadlines, meeting dates, etc.

+ Occasionally presents at IRB educational workshops and attends clinical and basic science meetings to assist IRB management team in answering questions.
+ Bachelor's Degree in related field
2 years of practical experience processing IRB submissions.
Attended and successful completion of PRIM&R 101
Knowledge, Skills and Abilities
+ Organizational skills and ability to multi.task.

+ Competence in using Microsoft Excel© and working with databases.
Licenses and Certifications
Working Conditions/Physical Demands

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