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.Developing new clinical trials and acting as the main contact during the protocol development phase.Corresponding with the reviewing committees and personnel.Assisting in budget development by identifying research non-billables.Coordinating start-up meetings for new protocols.Acting 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 will serve as 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 Union
Campus: MOSES
Employment Status: Regular Full-Time
Address: 1575 Blondell Avenue, Bronx
Shift: Day
Scheduled Hours: 9 AM-5:30 PM
Req ID: 223315
Salary Range/Pay Rate: $67,500.00 - $90,000.00
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