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Position Summary:
We have an exciting opportunity to join our team as a Senior Specialist - IRB Operations.

Reporting to the Associate Director of the IRB, the Sr. Specialist is responsible for the efficient processing of new expedited and exempt studies from submission to approval within expected turnaround time and acts as the primary liaison with relevant investigators related to these submissions. When required, the Sr. Specialist provides coverage for other Senior Specialists responsibilities. The Sr. Specialist will provide sick and vacation coverage for a Scientific Manager responsibility related to processing of new expedited and exempt studies.

Job Responsibilities:

• Performs pre-review and final review of new expedited and exempt studies and works with Scientific Manager on special cases/issues, such as vulnerable populations, drug or device research, genetic research, etc. to ensure regulatory criteria met and/expert review is obtained.
• Evaluates completeness and accuracy of submitted study documents and required documentation using IRB pre-review checklists to ensure compliance with NYU Langone Health policies and procedures, applicable federal, state and local law, and Good Clinical Practices
• Assesses whether a submission requires an IND/IDE and guides the Principal Investigator (PI) with the application process if necessary
• Analyzes submission documents (protocol, consent and other relevant documents) for completeness, and communicates all identified deficiencies to investigators via electronic submission systems clarification request
• Conducts regular follow-up with PIs on all outstanding issues resulting from pre-review for all new expedited and exempt studies
• Ensures all decisions for Exempt and Expedited are relayed to PI through official IRB correspondence in electronic system
• Makes determination on any submissions that qualify for full board review and liaise with the Full Board Senior Scientific Manager once the confirmation with Scientific Manager is obtained.
• Serves as a designated reviewer and performs all final determinations on the new submissions of expedited and exempt categories
• Provides organized and planned educational sessions for research community
• Attends annual professional conferences
• Maintains education and training to ensure current and up to date knowledge for all job-related aspects
• Works with the Associate Director on special projects, policy formulation and protocol specific issues as necessary
• Provides input and suggest changes to workflow processes for all areas of responsibility in order to improve efficiency
• Considers research community and any external partners while performing responsibilities and suggests system or process related improvements to ensure efficiency
• Provides guidance and assistance to researchers and IRB staff through education and training
• Works with Education Manager to draft and/or present education and training and generates input for any educational materials for distribution to research community and other communications
• Provides support and assistance for any additional work as required by the Associate Director
• Liaise with affiliate research committees and administrative staff (e.g., CIMU, MCIT) to identify additional deficiencies and/or to determine that requisite approvals have been received. Conduct quality assurance reviews using weekly database reports and/or searches to determine status of workload. Provide organized and planned educational sessions for research community.

Minimum Qualifications:
To qualify you must have a Bachelor's degree in healthcare related field.  Must be able to work independently with minimal supervision. Must exercise a high degree of independent judgment and discretion relating to research protocol issues. Proficiency in use of computer and relevant software and database applications (IRB Software, MS Word, PowerPoint, etc.). Certified IRB Professional (CIP) or Certified IRB Manager (CIM) certification preferred OR to be obtained within 1 year of employment

Preferred Qualifications:
Three or more management or supervisory experience is strongly preferred.

Qualified candidates must be able to effectively communicate with all levels of the organization.

NYU Grossman 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 Grossman 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. We require applications to be completed online.
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