SENIOR REGULATORY CONSULTANT (JR229099)

ViziRecruiter,LLC.; New York (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading cancer treatment center in New York is seeking a Senior Regulatory Compliance Coordinator to oversee clinical trials and ensure compliance with regulatory standards. You will work closely with investigators, manage regulatory submissions, and mentor junior staff. A Bachelor’s degree in Life Science or Health Policy is required, with a Master’s preferred. Ideal candidates will have a minimum of 4 years of experience in regulatory affairs or clinical research and relevant certifications. This position offers a critical role in advancing cancer research.

Qualifications

• Bachelor’s Degree Required, preferably in Life Science or Health Policy.
• Master’s Degree preferred.
• SOCRA or ACRP certification preferred.
• Minimum 4 years of research experience in relevant fields.

Responsibilities

• Manage clinical studies and ensure regulatory integrity from approval to closure.
• Mentor junior staff and provide oversight and training to study teams.
• Act as a resource for Investigators and Research Teams.

Skills

Regulatory Affairs knowledge

Clinical trial management

Mentoring and training

Education

Bachelor’s Degree in Life Science or Health Policy

Master’s Degree (preferred)

Job description

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

A Senior Regulatory Compliance Coordinator works under the direction of the Director of Regulatory Affairs and Compliance in Cancer Clinical Trials Office at the Montefiore Einstein Comprehensive Cancer Center. 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.

Requirements

Education Requirements:

• Bachelor’s Degree Required (preferred Life Science or Health Policy)
• Preferred Education Requirements: Master’s Degree (preferred Life Science or Health Policy)

Certifications:

• SOCRA or ACRP certification preferred.

Prior Experience:

• Minimum 4 years of research experience in Regulatory Affairs, Clinical Affairs or Quality Assurance