ASSOCIATE DIRECTOR IRB REGULATORY

This person is responsible to manage and deliver programmatic support to initiate cancer clinical trials for a designated Disease and Modality Team (DMT) at the Montefiore Einstein Comprehensive Cancer Center in an expeditious and compliant manner. Specific responsibilities include all pre-activation activities. Serves as the internal senior leader and mentor for assigned cancer DMT(s), providing the group with timely updates on the status of submissions and regulatory guidance on study development. Liaise with sponsors, study investigator, 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.

Serve as the key opinion leader (KOL) on all topics related to regulatory compliance to maintain compliance with local, state, and federal regulations. Supervise, trainer and mentor junior regulatory associates/IRB consultants within the DMT.

EDUCATION, TRAINING, LICENSES, REGISTRATIONS, PROFESSIONAL CERTIFICATIONS, AND WORK EXPERIENCE

• Masters Degree in Life Science or Peublic Health Required
• ACRP or SOCRA required within 24 months of employment
• 5 years of relevant experience in oncology regulatory affairs including prior experience from study start up to close out.
• Working knowledge of local, state, federal and international government codes/regulations related to the conduct of human subject research
• Excellent working knowledge of regulatory compliance requirements and procedures
• Extensive knowledge of oncology clinical trials and oncology terminology
• Exceptional communication, analytical, presentation and time management skills
• Comfortable working in clinical trial management systems and electronic regulatory binder systems
• Working knowledge of MS Office suites, database, spreadsheets, graphic and communications applications.
• Qualified candidates must be able to effectively communicate with all levels of the organization
• Extensive experience with CTMS and other clinical trial electronic systems (CTMS, EPIC, VELOS, COMPLION) are highly desirable

Department: Oncology Bargaining Unit:Non UnionCampus:MOSES Employment Status:Regular Full-TimeAddress:111 East 210th Street, Bronx

Shift:DayScheduled Hours:8:30 AM-5 PMReq ID:222872Salary Range/Pay Rate:$90,000.00-$120,000.00

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.

Diversity, equity and inclusion are core values of Montefiore. We are committed to recruiting and creating an environment in which associates feel empowered to thrive and be their authentic selves through our inclusive culture. We welcome your interest and invite you to join us.

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