DIRECTOR REGULATORY AFFAIRS CCTO
: Job Details :

Overview

City/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: $96,000.00-$120,000.00

Responsibilities

The Director of Regulatory Affairs and Compliance, reporting to the Senior Director, Cancer Clinical Research Administration, will design, develop, implement and monitor an effective regulatory affairs team, including overseeing the Montefiore Einstein Comprehensive Cancer Center Clinical Trials Office Regulatory Coordinators. The position works closely with the MECCC CCTO, Einstein IRB and BRANY IRB leadership, Montefiore and Albert Einstein research communities to ensure operational efficiency and compliance with laws, regulations, standards, and institutional requirements that impact human research. This position creates functional strategies and specific objectives for the regulatory team, developing workflows, implementation of policies and procedures, monitoring compliance, educating colleagues and assessing performance of employees to support the functional infrastructure. The individual will liaise with sponsors, study investigators, BRANY, Montefiore Einstein Office of Clinical Trials, Albert Einstein College of Medicine and BRANY Institutional Review Boards (IRBs), General Counsel, and internal study teams and departments. In addition, the Director will provide oversight and direct supervision of staff completing the NCI mandated reporting through CTRP and oversight of the reporting to clinicaltrials.gov in accordance with Federal Regulations and requirements.

Qualifications

• Masters degree required
• 7 years of related experience
• ACRP or SOCRA required within 24 months of employment
• Working knowledge of local, state, federal and international government codes/regulations related to the conduct of human subject research
• Extensive knowledge of oncology clinical trials and oncology terminology
• Comfortable working in clinical trial management systems and electronic regulatory binder systems
• Extensive experience with CTMS and other clinical trial electronic systems (CTMS, EPIC, VELOS, COMPLION) are highly desirable
• Qualified candidates must be able to effectively communicate with all levels of the organization

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.

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