SENIOR REGULATORY CONSULTANT (223315)
: Job Details :

Join to apply for the 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

IntroductionTo 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.OverviewCity/State: Bronx, New YorkGrant Funded: YesDepartment: Cancer Clinical Trials OfficeWork Shift: DayWork Days: MON-FRIScheduled Hours: 9 AM-5:30 PMScheduled Daily Hours: 7.5 HOURSPay Range: $72,000.00-$90,000.00A 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 levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionLegal
• IndustriesHospitals 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 AffairsRegulatory 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