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. For more information, go to med.nyu.edu, and interact with us on LinkedIn, Glassdoor, Indeed, Facebook, Twitter and Instagram. Position Summary:
We have an exciting opportunity to join our team as a Sr Specialist-IRB Operations.
Reporting to the Senior Scientific Manager – Full Board (SSM) of the IRB, The Senior Specialist (SS) is responsible for the efficient operation of all processes related to the full board ongoing pre-review activities, including minutes preparation. In addition, the SS is responsible for managing and processing initial full board modifications and continuing reviews from submission to approval within expected turnaround time when coverage is required. The SS also provides vacation and sick leave coverage to other SS’s. Job Responsibilities: - Evaluates all Full Board initial submission materials to determine consistency with IRB requirements for approval, including all NYU Langone Health Policies, applicable federal, state, and local law, and Good Clinical Practices
- Attends weekly board pre-meeting briefing and performs post-review specialist responsibilities
- Attends weekly board meeting and performs post-review specialist responsibilities including guiding IRB members to make the necessary required findings
- Generates approval letters and issues letter for all new submissions
- Attends debriefings (and leads as requested by AD) following board meetings to ensure understanding of the determinations, which will be used to generate minutes and letters
- Writes all approval and modification letters
- Develops elements of the meeting agenda and assigns reviewers when required
- Provides guidance, education, and assistance in IRB submission activities to research staff
- Ensures communications with research teams are recorded in an appropriate communication filing system
- Ensures all decisions for new study submissions are relayed to Principal Investigator (PI) through official IRB correspondence in electronic system
- Serves as a designated reviewer and performs all final determinations on the new submissions of expedited and exempt categories
- Analyzes submission documents (protocol, consent and other relevant documents) for completeness consistent with board decision and communicates all identified deficiencies to investigators via the electronic submission systems clarification request
- When acting as a pre-reviewer for initial submissions:
Assesses whether the submission requires an IND/IDE and guides the PI with the application process if necessary
Determines, write, and relays deficiencies in IRB submissions clearly and concisely to PIs through official pre-review correspondence via email
Conducts regular follow up with PIs on all outstanding issues resulting from pre-review correspondence
Works with researchers to revise submissions and prepares for final board review or designated review - Provides support and assistance for any additional work as required by the AD
- Assists the AD with special projects, policy formulation, and protocol related issues
- Obtains CIP certification or equivalent within 1 year of employment
- Write and relay clear and concise response review issues to PI through Research Navigator
- Develop PowerPoint presentations and participates in education and training sessions for the research community alongside IRB Education Manager
- Provides day-to-day operations support for reliance coordinators as required, including:
Approving the use of NYUGSOM IRB as a Single IRB (sIRB)
Approving the use external IRBs based on institutional policies
Processing reliance agreements
Guiding investigators in complying with institutional requirements applicable to sIRB and external IRB processes
Communicating with relying institution teams to facilitate IRB approvals
Additional Position Specific Responsibilities:
Additional Position Responsibilities:
Ensures all submissions are entered in electronic database system on a daily basis and all communications with researchers are logged in appropriate communication filing system
Liaises with affiliate research committees and administrative staff (e.g., CTSI, PRMC) to identify additional deficiencies and/or to determine that requisite approvals have been received
Conducts quality assurance reviews using weekly database reports and/or searches to determine status of workload
Provides organized and planned educational sessions for research community
Minimum Qualifications: - Bachelor’s degree in a health related field
- Three + years’ experience in clinical research and/or IRB regulatory work.
- 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.)
Preferred Qualifications: - Certified IRB Professional (CIP) or Certified IRB Manager (CIM) certification preferred OR to be obtained within 1 year of employment.
- Master’s Degree
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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