ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI

Senior Regulatory Compliance Coordinator

A-22245-16332 H-4 2023 Certified

Salary

$86,757

Visa Type

H-4

Job Title

Senior Regulatory Compliance Coordinator

Employee's Citizenship

INDIA

Graduate School

LONG ISLAND UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22245-16332

Case Status Certified

Received Date 2022-10-11

Decision Date 2023-08-24

Refile N

Original File Date -

Previous State Work Force Agency (SWA) Case Number Stete -

Schedule A or a Sheepherder Occupation N

Company Info

14 fields

Employer Name ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI

Employer Address_Line 1 1468 MADISON AVENUE

Employer Address_Line 2 -

Employer City NEW YORK

State -

Employer State/ Province NEW YORK

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 10029

Employer Phone No. 2122418300

Employer Phone Extent No. -

Total Number of Employees 14000

Employer Year of Commenced 1964

NAICS Code 621399

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Hamel Vyas

Employer Contact Address Line1 One Gustave L. Levy Place

Employer Contact Address Line2 -

Employer Contact City New York

Employer Contact State/ Provice NEW YORK

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 10029

Employer Contact Phone (212) 241-8300

Employer Contact Email hamel.vyas@mountsinai.org

Attorney

11 fields

Agent/ Attorney Name Michelle S Velasco

Agent/ Attorney Firm Name Kramer Levin Naftalis Frankel LLP

Agent/ Attorney Phone (212) 715-9521

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 1177 Avenue of the Americas 23rd Floor

Agent/ Attorney Address Line 2 -

Agent/ Attorney City New York

Agent/ Attorney State/ Province NEW YORK

Agent/ Attorney Country UNITED STATES OF AMERICA

Agent/ Attorney Postal Code 10036

Agent/ Attorney Email mvelasco@kramerlevin.com

Position Info

89 fields

Prevailing Wage Track Number P10022084010920

Prevailing Wage SOC Code 13-1041

Prevailing Wage SOC Title Compliance Officers

Prevailing Wage Skill Level Level III

Prevailing Wage 86757

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-10-03

Prevailing Wage Expiration Date 2023-06-30

Wage Offer From 92700

Wage Offer To -

Wage Offer Unit of Pay Year

Workstie Address Line 1 1425 Madison Avenue

Worksite Address Line 2 3rd Floor

Worksite City New York

Worksite State NEW YORK

Worksite Postal Code 10029

Job Title Senior Regulatory Compliance Coordinator

Minimum Education Master's

Other Degree/ Diploma -

Major Field of Study Health Science

Required Training N

Required Training Month -

Required Field of Training -

Required Experience Y

Required Expreience Months 36

Accept Alternate Field of Study Y

Accept Alternate Major Health Policy, Drug Regulatory Affairs, or related discipline

Alternate Combination of Education/ Experience N

Required Alternate Level of Education -

Other Alternate Level of Education -

Acceptable Years of Experience -

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 36

Accept Alternate Job Title Regulatory Specialist at a hospital or medical services group

Normal Requirements of Job Opportunity Y

Required Foreign Language N

Specific Skills Masters Degree in Health Science, Health Policy, Drug Regulatory Affairs, or related discipline, plus three years of experience in the position offered or as a Regulatory Specialist at a hospital or medical services group.br br All required experience must have included conducting project management, quality assurance, research administration and compliance for clinical trial protocols; interpreting complex scientific terminology and exhibit expertise in local, state, and federal regulations and guidelines, such as FDA 21 CFR specifically parts 11, 50, 54, 56 and 58 and principles of Good Clinical Practice GCP; managing the FDA and institutional review board IRB submission process and completing regulatory documentation and associated forms for clinical trial projects from protocol development through closure; developing, reviewing and completing protocol essential documents Informed Consent Form, Designee Form, etc.; entering clinical trial protocol and related information into medical electronic tracking software OnCore, hospital EMR system and various IRB local, BRANY, WIRB, ADVARRA electronic databases; developing multicenter tools such as site activation questionnaire, site activation checklist, site welcome memo, and site closeout visit checklist; managing multicenter sites through MS One Drive Box; preparing and distributing pertinent study related updates to participating sites; and providing oversight and guidance per regulations using knowledge of international regulations and requirements needed for collaborations.

Combination Occupation N

Offered to Applied Foreign Worker Y

ForeignWorker Live on Premises N

Live in Domestic Service Worker N

Employment Contract -

Professional Occupation Y

College/ University Teacher N

Competitive Process -

Basic Recruitment Process -

Teacher Select Date -

Teacher Publish Journal Name -

Additional Recruitment Information -

Job Oder Start Date 2022-06-23

Job Oder End Date 2022-07-25

Sunday Edition Newspaper Y

First Newspaper Name The New York Times

First Advertisement Start Date 2022-07-17

Second Newspaper Name The New York Times

Second Advertisement Type Newspaper

Second Ad Start Date 2022-07-24

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date -

Employer Website to Date -

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-07-17

Job Search Website to Date 2022-07-31

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date -

Employee Referral Program to Date -

Campus Placement from Date -

Campus Placement to Date -

Local Ethnic Newspaper from Date 2022-07-19

Local Ethnic Newspaper to Date 2022-07-19

Radio/TV Ad from Date 2022-07-21

Radio/TV Ad to Date 2022-07-21

Employer Received the Payment N

Payment Details -

Bargaining Representative Notified N/A

Posted Notice at Worksite Y

Layoff in Past Six Months N

US Worker Considered -

Country of Citizenship INDIA

Foreign Worker Birth Country INDIA

Class of Admission H-4

Employee Info

24 fields

Foreign Worker Education Master's

Foreign Worker Education Other -

Foreign Worker Major DRUG REGULATORY AFFAIRS

Year of Compelted Education 2016

Foreign Worker Istitution of Eduation LONG ISLAND UNIVERSITY

Foreign Worker Education Instution Address Line 1 BROOKLYN CAMPUS, 1 BROOKLYN PLAZA

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City BROOKLYN

Foreign Worker Educatution Institution State NY

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 11201

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N

Foreign Worker Alternate Education and Experience N/A

Foreign Worker Alternate Occupation Experience Y

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay for Education N

Foreign Worker Currently Employed Y

Employer Completed Application N

Preparer Name Michelle S Velasco

Preparer Title Attorney

Preparer Email mvelasco@kramerlevin.com

Employer Information Declaration Name Hamel Vyas

Employer Declaration Title Associate Dean, International Personnel, HR