What are the responsibilities and job description for the SENIOR REGULATORY CONSULTANT position at Montefiore Health System?
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, and coordinating 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.
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
Make your application after reading the following skill and qualification requirements for this position.
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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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 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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Salary : $67,500 - $90,000
