SENIOR REGULATORY CONSULTANT

City/State:

Bronx, New York

Grant Funded:

Yes

Department:

Cancer Clinical Trials Office

Work Shift:

Day

Work Days:

MON-FRI

Scheduled Hours:

9 AM-5:30 PM

Scheduled Daily Hours:

7.5 HOURS

Pay Range:

$72,000.00-$90,000.00

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.   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.

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

Montefiore Medical Center is an equal employment opportunity employer. Montefiore Medical Center 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 of disability, 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.