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Position Summary: We have an exciting opportunity to join our team as a Sr. Scientific Res Mgr I (IRB).
In this role, the successful candidate Reporting to the Associate Director of the IRB, the Sr. Scientific Research Manager is responsible for pre-review, final approval and all processes related to final determination for post-approval expedited submission action items (projects having already received initial approval by the IRB) and acts as the primary liaison with the relevant investigators. The Sr. Scientific Research Manager must ensure that post-approval expedited items are processed within the expected turnaround time. The Sr. Scientific Research Manager will also provide vacation and sick leave coverage for other Sr. Scientific Research Manager.
Oversee day-to-day operations for assigned expedited submission items for projects having received prior IRB approval.
Perform pre-review and final review of continuations, amendments and study closures that qualify for expedited review in accordance with NYU SoM 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 NYUSoM 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 continuations, amendments, and responses.
Make determination and approval of expedited continuations and amendments.
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 and liaise with the Sr. Scientific Research Manager.
Ensure that all submissions are data entered in electronic database system on a daily basis.
Attend board meetings as a voting member when necessary.
Provide vacation and sick coverage for other Sr. Scientific Research Manager when necessary.
Management of all expedited submission action items and the post-approval expedited team when covering for other post-approval Sr. Scientific Research Manager.
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 and when necessary work to resolve any issues.
Liaise with affiliate research committees and administrative offices (OCT, COIC, CTSI, PRMC, RPRG) to identify and communicate any additional deficiencies and/or to determine that requisite approvals have been received when appropriate.
Based on pre-review and communications with PI, if applicable, recommend to Senior Scientific • Research Manager whether to schedule full board review of a submission. Relay this decision to PI both verbally and through official IRB correspondence in electronic mail format.
Work with associated pre-review staff when necessary to formulate clarification request regarding identified deficiencies to Investigators.
Ensure all decisions are relayed to PI through official IRB correspondence in electronic format.
Ensure that all review communications are relayed to PI and research team
Ensure all communications with researchers are logged in appropriate communication filing system.
Provide high-level guidance and assistance to researchers and IRB staff; through education and training.
Provide organized and planned educational sessions for the research community.
Attend annual professional conferences.
Maintain education and training to ensure current and up to date knowledge of all job-related aspects.
Work with Associate Director on special projects, policy formulation and protocol specific issues as necessary
Provide support and assistance for any additional work as required by Associate Director.
To qualify you must have an MA, MPH, MS, RN. Solid command of human subject regulations and policies.
Must exercise a high degree of independent judgment and discretion relating to research protocol issues.
Superior organizational, analytical, time management, multi-tasking and interpersonal communication skills required.
Excellent verbal and technical writing skills, proficient use of computer and relevant software and database applications (IRB Software, MS Word, PowerPoint, etc.)
Three + years experience in clinical research and/or IRB regulatory work.
Certified IRB Professional (CIP) certification preferred OR to be obtained within 1 year of employment.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you’ll feel good about devoting your time and your talents.
NYU School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision.