SENIOR REGULATORY CONSULTANT

Introduction

To heal, to teach, to discover and to advance the health of the communities we serve.

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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