SENIOR REGULATORY CONSULTANT

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. 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.

EDUCATION, TRAINING, LICENSES, REGISTRATIONS, PROFESSIONAL CERTIFICATIONS, AND WORK EXPERIENCE:

• 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.

Department: Oncology Bargaining Unit:Non UnionCampus:MOSES Employment Status:Regular Full-TimeAddress:1575 Blondell Avenue, Bronx

Shift:DayScheduled Hours:9 AM-5:30 PMReq ID:222896Salary Range/Pay Rate:$71,250.00-$95,000.00

For positions that have only a rate listed, the displayedrate is the hiringrate but could be subject to change based on shift differential, experience, education or other relevant factors.

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