Senior Scientific Manager - Human Research Protections

Senior Scientific Manager
- Human Research Protections

Research -->
Administration

New York, NY

Full-Time/Regular

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care.

At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge.

For more information, go to med.nyu.edu, and interact with us on Linked In, Glassdoor, Indeed, Facebook, X and Instagram.

We have an exciting opportunity to join our team as a Senior Scientific Manager
- Human Research Protections.

• Oversee day-to-day operations of post-approval team including
• Conduct quality assurance reviews using weekly database reports and/or searches to determine status of workload.
• Ensure that evaluations and deficiencies of submissions are communicated to PI by the pre-review staff and when necessary work to resolve any issues.
• Work with associated pre-review staff when necessary to formulate clarification request regarding identified deficiencies to Investigator
• Perform final review of continuations, amendments and study closures that qualify for expedited review in accordance with NYU LH policy and procedures and federal regulations including
• Verify the completeness and accuracy of the application and the required documentation using the appropriate review checklist.
• Thoroughly analyze the submission documents (protocol, consent and other relevant documents) to ascertain compliance with NYULH policies & procedures, applicable federal, state and local law, and Good Clinical Practices.
• When required, conducts regular follow-up with PIs on all outstanding issues resulting from pre-review for all continuations, amendments and responses.
• Perform pre-review of RNIs in accordance with NYULH policy and procedures and federal regulations including:
• Verify the completeness and accuracy of the application and the required documentation using the appropriate review checklist.
• Thoroughly analyze the submission documents (protocol, consent and other relevant documents) to ascertain compliance with NYULH policies & procedures, applicable federal, state and local law, and Good Clinical Practices.
• Conduct regular follow-up with PIs on all outstanding issues resulting from pre-review for all RNIs..
• Ensure all decisions are relayed to PI through official IRB correspondence in electronic mail format.
• Make final determination on any submissions (continuation or amendment) that qualify for full board review
• Ensure that all submissions are data entered in electronic database system on a daily basis
• Attend board meetings as a voting member when necessary.
• When necessary, oversee day-to-day operations of New Study Team and coverage of Scientific Managers for review of Full Board and Expedited new submissions
• Provide vacation and sick coverage for other Sr. Scientific Research Manager and Scientific Managers when necessary.
• Provide high-level guidance and assistance to researchers and IRB staff; through education and training.
• Provide organized and planned educational sessions for research community.
• Attend annual professional conferences
• Maintain education and training to ensure current and up to date knowledge for all job related aspects.
• Work…