SENIOR REGULATORY CONSULTANT Position Available In Bronx, New York

SENIOR REGULATORY CONSULTANT

Montefiore Medical Center United States, York, Bronx Jun 20, 2025 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:

223315

Salary Range/Pay Rate:

$67,500.00-$90,000.00 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. To learn more about the “Montefiore Difference” – who we are at Montefiore and all that we have to offer our associates, please clickhere. Montefiore is an equal employment opportunity employer. Montefiore will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history ofdisability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status,or partnership status, or any other characteristic protected by law. N/A; #LI-AA1; #LI-TM1; #LI-VK1