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Biomedical Research Alliance of New York / BRANY IRB COORDINATOR - Remote in Lake Success, New York

We do not consider incomplete or Quick Apply applications. *Duties/Responsibilities: 1. The mission of the BRANY Institutional Review Board (IRB) is to protect the rights and ensure the welfare of all human research subjects. Therefore, the IRB Coordinator must maintain current knowledge of OHRP and FDA regulations, NIH Guidelines and BRANY IRB Standard Operating Procedures, as well as current guidance in human subject protections, GCP, and AAHRPP accreditation standards. Maintenance of this knowledge will be accomplished via continuing education conducted at IRB team meetings, and/or applicable professional meetings or educational seminars/programs attended.2. Evaluates submissions to the IRB for completeness, accuracy, and applicable required components based on submission type. 3. Determines level of IRB review required. Prepares and processes submissions for IRB review, including preparation of reviewer checklists, managing materials reviewed by IRB, and maintaining IRBManager events and records.4. Ability to communicate with researchers, committee members, consultants and other research professionals regarding regulatory requirements, protocol design, consent, HIPAA, and other research study requirements. 5. Attend IRB meetings and ensure that for all items on the IRB meeting agenda the required regulatory determinations are considered, and committee questions are addressed sufficiently to facilitate the IRB's decision and voting. 6. Serves as a resource for assigning IRB reviewers.7. Ensures that investigators, sponsors/CROs and applicable Clinical Trials Activation Team (CTAT). members are advised of IRB decisions in writing within established timelines for submission type.8. Implements directed changes to consent forms, assent forms or other materials when requested by IRB reviewers and ensures proper re-review as needed (i.e. IRB review of revisions required by the IRB to secure approval, either by expedited or convened IRB review). 9. Prepares weekly and monthly submission reports, analyzing submissions and including a recommended action plan to move submissions forward within or under the established time frame target for the submission type.10. Manages submissions to ensure efficient interaction between IRB reviewers and IRB staff. Provides feedback to supervisor(s) regarding the IRB submissions and offers suggestions for changes or improvements as necessary. 11. Properly processes assigned IRB submissions, recognizing the turnaround time targets, and with attention to detail. Updates relevant parties, databases and Excel spreadsheets once approval has been issued.12. Maintain and update information in BRANY computer databases (IRBManager, SMART, etc.) as applicable. Follow up on pending events in IRBManager to ensure the program runs more efficiently. Assist with implementation of database revisions/enhancements as needed.13. Able to manage multiple projects with varying deadlines and changing requirements.14. Attend webinars, and conferences in order to remain updated on trends in human research protection and the application of federal regulations and guidance.15. Trains and develops new or inexperienced BRANY or IRB staff.16. Assists Director of the IRB or Department staff in other activities as needed. 17. Uses communication skills to establish and maintain good working relationships with IRB members, doctors, site liaisons, investigators, CRO representatives, and sponsors.18. Uses writing skills to effectively communicate via email and written correspondence.19. Works independently, takes initiative and troubleshoot daily routine problems as they occur. Develop or recommend a plan of corrective action for complex non-routine issues.20. Works as a team member on special nonrecurring and ongoing projects. ()Non-Essential Functions will be noted by asterisk (*). Education required: Bachelor's Degree or equivalent experience. Science or Health related degree preferred.

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