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, diversity, 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 diversity, inclusion, and individual skills, ideas, and knowledge. 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 Senior Specialist-Institutiona.

Reporting to the Senior Scientific Manager (SSM) of the IRB, the Senior Specialist (SS), full board team is responsible for pre-review of all new full board submission action items from board review until the issuance of final approval notification. The SS attends all board meetings, generates communication of all board decisions for new submissions and writes minutes for all board meetings. Provides training, supervisions and day-to-day guidance to other Full Board team members.

MAJOR DUTIES AND RESPONSIBILITIES:

• Conduct a review of all new and response full board agenda items in preparation for meetings of Boards A, B, C, D, F, and G
• Verify the completeness and accuracy of each new and response full board agenda item and the required documentation in accordance with NYU SOM IRB policies and procedures, applicable federal, state and local law and Good Clinical Practices
• Evaluate all submission materials to determine consistency with IRB requirements for approval, including all NYU SoM Policies, applicable federal, state and local law and Good Clinical Practices and works with researchers to correct deficiencies prior to board review.
• Write and relay clear and concise response review issues to PI through Research Navigator
• Prepare for all IRB meeting; phone lists, tape recorder, any paper copies and appropriate power point slides. 
• Ensure all communications with research teams are recorded in appropriate communication filing system.
• Attend all IRB meetings.
• Record all controverted issues and their resolution and Board determinations.
• Participate in debriefings following Board meetings to verify understanding of the determinations
• Generate all board determination (approval and issue) letters documenting all IRB determinations for all new reviews and responses
• Develop, generate and distribute meeting minutes to the SSRM for pre-review, thereafter, Associate Director and QA & I Manager, prior to distribution to the Chair, Director and appropriate Board for review and approval
• Verify the completeness and accuracy of Conditional Approval responses for new full board agenda items in accordance with NYU SOM IRB policies and procedures, applicable federal, state and local law and Good Clinical Practices
• Conduct regular follow-up with PIs on all outstanding issues resulting from Deferrals and Conditional approvals of new studies correspondence
• Develop elements of the meeting agenda and assign reviewers when required
• Provide guidance and training to the Full Board IRB staff to educate and assist them in IRB submission activities
• Supervises Full Board team as required by SSRM and as part of SSRN coverage
• Attend Board E meeting and perform post review specialist responsibilities as coverage for Sr. IRB Specialist
• Performs Full Board new study reviews from submission to approval when required
• Develop power point presentations and participate in education and training sessions for research community. This will require working with IRB Education Manager
• Provide coverage of aspects of the senior scientific managers responsibilities when the manager is not available; agenda, review of letters, interact and direct staff and communicate with research teams to resolve issues related to IRB determinations
• Obtain CIP certification within 1 year of employment or within one year of completing eligibility
• Assist the SSM with special projects, policy formulation and protocol specific issues
• Provide support and assistance for any additional work as required by the Director

MINIMUM QUALIFICATIONS:

To qualify you must have a Associates degree required OR Bachelor's Degree with relevant experience or the equivalent combination of education and experience. 3-5 years IRB regulations and documentation. 1-2 years Management or supervisory. Excellent communication (both oral and written), interpersonal, strong organizational, leadership, prioritization, problem solving and deductive reasoning skills. Knowledgeable of applicable federal regulations related to Institutional Review Board and Clinical research. Knowledgeable inHuman Subject Research. Basic computer skills including MS Office.

PREFERRED QUALIFICATIONS: BA/BS; 1-2 years of experience and knowledge directly related to IRB related work; Must be able to work independently with minimal supervision;

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. If you wish to view NYU Grossman School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information. To view the Pay Transparency Notice, please click here.

Required Skills Required Experience