Montefiore Health System
SENIOR REGULATORY CONSULTANT (223315)
Montefiore Health System, New York, New York, us, 10261
Join to apply for the
SENIOR REGULATORY CONSULTANT (223315)
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Montefiore Health System 5 days ago Be among the first 25 applicants Join to apply for the
SENIOR REGULATORY CONSULTANT (223315)
role at
Montefiore Health System Get AI-powered advice on this job and more exclusive features. Montefiore Health System provided pay range
This range is provided by Montefiore Health System. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$72,000.00/yr - $90,000.00/yr Introduction
To heal, to teach, to discover and to advance the health of the communities we serve.
To learn more about the “Montefiore Difference” – who we are at Montefiore and all that we have to offer our associates, please click here.
Overview
City/State:
Bronx, New York
Grant Funded:
Yes
Department:
Cancer Clinical Trials Office
Work Shift:
Day
Work Days:
MON-FRI
Scheduled Hours:
9 AM-5:30 PM
Scheduled Daily Hours:
7.5 HOURS
Pay Range:
$72,000.00-$90,000.00
A Senior Regulatory Compliance Coordinator position is currently available within the Montefiore Einstein Cancer Center Clinical Trials Office (CCTO). The incumbent will work with investigators and the CCTO infrastructure to manage cancer clinical trials for the division.
Responsibilities
Duties include, but are not limited to, management of clinical studies through the regulatory portion of the trial submission process, ensuring regulatory integrity of assigned clinical trials from approval to closure, develop new clinical trials and act as the main contact during the protocol development phase, correspond with the reviewing committees and personnel, assist in budget development by identifying research non-billables, and coordinate start-up meetings for new protocols. The Senior Regulatory Compliance Coordinator will act as a mentor to junior staff- providing oversight and training to multiple study teams who develop and submit documentation and information for Institutional Review Board (IRB) review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies. The Senior Regulatory Compliance Coordinator is a resource for Investigators and Research Teams. The position will report into the Assistant Director of Regulatory Compliance.
Requirements
Bachelors Degree in Science or Health Policy required Masters Degree in Science or Health Policy preferred SOCRA or ACRP certification preferred. Minimum of 4 years of research experience in Regulatory Affairs, Clinical Affairs or Quality Assurance with wide knowledge of Phase I-IV clinical studies and data management aspects of clinical research. Working knowledge of Good Clinical Practice guidelines and Code of Federal regulations Oncology experience required; some medical knowledge preferred.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Legal Industries Hospitals and Health Care Referrals increase your chances of interviewing at Montefiore Health System by 2x Sign in to set job alerts for “Regulatory Affairs Consultant” roles.
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SENIOR REGULATORY CONSULTANT (223315)
role at
Montefiore Health System 5 days ago Be among the first 25 applicants Join to apply for the
SENIOR REGULATORY CONSULTANT (223315)
role at
Montefiore Health System Get AI-powered advice on this job and more exclusive features. Montefiore Health System provided pay range
This range is provided by Montefiore Health System. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$72,000.00/yr - $90,000.00/yr Introduction
To heal, to teach, to discover and to advance the health of the communities we serve.
To learn more about the “Montefiore Difference” – who we are at Montefiore and all that we have to offer our associates, please click here.
Overview
City/State:
Bronx, New York
Grant Funded:
Yes
Department:
Cancer Clinical Trials Office
Work Shift:
Day
Work Days:
MON-FRI
Scheduled Hours:
9 AM-5:30 PM
Scheduled Daily Hours:
7.5 HOURS
Pay Range:
$72,000.00-$90,000.00
A Senior Regulatory Compliance Coordinator position is currently available within the Montefiore Einstein Cancer Center Clinical Trials Office (CCTO). The incumbent will work with investigators and the CCTO infrastructure to manage cancer clinical trials for the division.
Responsibilities
Duties include, but are not limited to, management of clinical studies through the regulatory portion of the trial submission process, ensuring regulatory integrity of assigned clinical trials from approval to closure, develop new clinical trials and act as the main contact during the protocol development phase, correspond with the reviewing committees and personnel, assist in budget development by identifying research non-billables, and coordinate start-up meetings for new protocols. The Senior Regulatory Compliance Coordinator will act as a mentor to junior staff- providing oversight and training to multiple study teams who develop and submit documentation and information for Institutional Review Board (IRB) review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies. The Senior Regulatory Compliance Coordinator is a resource for Investigators and Research Teams. The position will report into the Assistant Director of Regulatory Compliance.
Requirements
Bachelors Degree in Science or Health Policy required Masters Degree in Science or Health Policy preferred SOCRA or ACRP certification preferred. Minimum of 4 years of research experience in Regulatory Affairs, Clinical Affairs or Quality Assurance with wide knowledge of Phase I-IV clinical studies and data management aspects of clinical research. Working knowledge of Good Clinical Practice guidelines and Code of Federal regulations Oncology experience required; some medical knowledge preferred.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Legal Industries Hospitals and Health Care Referrals increase your chances of interviewing at Montefiore Health System by 2x Sign in to set job alerts for “Regulatory Affairs Consultant” roles.
Regulatory Affairs Supervisor - Cosmetics & Skincare
Totowa, NJ $67,000.00-$72,000.00 4 days ago Regulatory Affairs Manager - Medical Device
New York, NY $110,000.00-$125,000.00 3 months ago Associate Director, Global Regulatory Affairs
Regulatory Affairs Manager – New York City
New York, NY $140,000.00-$150,000.00 1 week ago Scientific & Regulatory Affairs- Sr. Specialist
Newark, NJ $107,071.00-$147,223.00 6 days ago Jersey City, NJ $125,000.00-$135,000.00 4 days ago East Hanover, NJ $83,000.00-$115,000.00 2 weeks ago Associate Director of Regulatory Affairs Strategy - 157064
New York, NY $145,000.00-$200,000.00 3 hours ago Senior Regulatory Affairs Specialist - Urgent Need
Secaucus, NJ $130,000.00-$140,000.00 2 months ago Senior Manager, Rates and Regulatory Affairs
Merrick, NY $142,018.00-$213,026.00 1 week ago New York City Metropolitan Area 1 week ago Franklin Lakes, NJ $106,600.00-$175,900.00 1 month ago New York, NY $150,000.00-$160,000.00 17 hours ago Assistant General Counsel, Regulatory Affairs
New York, NY $174,760.00-$287,102.50 2 weeks ago Manager Regulatory Affairs - Regulatory Information Management (RIM) System (Remote US)
Wayne, NJ $140,000.00-$175,000.00 17 hours ago Clark, NJ $126,900.00-$184,000.00 1 day ago New York, NY $150,000.00-$160,000.00 2 weeks ago Secaucus, NJ $130,000.00-$140,000.00 3 weeks ago New York City Metropolitan Area $125.00-$140.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr