SENIOR REGULATORY CONSULTANT (223315) - Montefiore Health System : Job Details

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IntroductionTo heal, to teach, to discover and to advance the health of the communities we serve.To learn more about the “Montefiore Difference” – who we are at Montefiore and all that we have to offer our associates, please click here .OverviewCity/State: Bronx, New YorkGrant Funded: YesDepartment: Cancer Clinical Trials OfficeWork Shift: DayWork Days: MON-FRIScheduled Hours: 9 AM-5:30 PMScheduled Daily Hours: 7.5 HOURSPay Range: $72,000.00-$90,000.00A 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.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.
• The position will report into the Assistant Director of Regulatory Compliance.

Requirements

• 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.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionLegal
• IndustriesHospitals and Health Care

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