PROGRAM DIRECTOR CCTO (JR227774)

Montefiore; New York (NY); Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Montefiore is seeking a Program Director to lead the daily operations, financial growth, and expansion of the Early Phase Therapeutics oncology clinical research program across multiple campuses. You will supervise data managers, research staff, and ensure compliance with applicable regulations.

You will coordinate start-up timelines, budgeting, and audits, collaborating with sponsors and industry partners to advance trial activities and quality clinical research across sites.

Formación

• Master's degree in Life Science or Public Health required.

Responsabilidades

• Train and onboard new study coordinators.
• Work with research team to manage each patient accrued to a study.
• Ensure billing compliance for Early Phase Therapeutics trials and review charges.
• Oversee start-up of protocols to maintain NIH/NCI timelines (<90 days).
• Review Medicare coverage analysis for procedure designations.
• Serve as liaison with pharmaceutical/biotech partners.
• Prepare for NIH, BRANY, Sponsor audits and FDA inspections.
• Participate on committees and perform other duties as assigned.

Conocimientos

Regulatory knowledge

Program leadership

Educación

Master's degree in Life Science or Public Health

MD or DDS (foreign equivalent)

Herramientas

CITI

ACRP/SOCRA certification within 24 months

IATA

Descripción del empleo

Introduction

To 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.

Overview

The Program Director is responsible for the daily operations, financial growth, and expansion of the Early Phase Therapeutics oncology clinical research program. Expansion of the Early Phase Therapeutics clinical research program can include the physical expansion of the program across multiple campuses, expansion of the capacity of clinical research program through the development of a research specific unit, and cultivation of relationships with key industry partners. This position will oversee daily operations across multiple campuses including the direct supervision of data managers, research associates and research technicians.

Responsibilities

• Responsible for training and on-boarding of new study coordinators.
• Work closely with research team (ProgramLeaders, co-investigators, research coordinators, research nurses, other data managers, and protocol office staff) in the management of each patient that is accrued to a study.
• Responsible for the billing compliance of the Early Phase Therapeutics trials, ensuring the proper ordering and association of consult and ancillary services (laboratory tests, imaging, etc.) as well as reviewing charges and designations once the visit is closed
• Manage clinical trials portfolio and assures timely start-up of protocols to maintain NCI expectations of < 90 days.
• Review Medicare coverage analysis for appropriate procedure level designations.
• Serve as the Early Phase Therapeutics clinical research program principle liaison with pharmaceutical and biotechology companies
• Prepare for NIH, BRANY and Sponsor audits and FDA inspections.
• Serve on departmental and institutional committees as necessary.
• Other duties as assigned.

Requirements

• Master's degree in Life Science or Public Health required.
• 5 years' related work experience.
• ACRP or SOCRA certification within 24 months of employment.
• MD, DDS (or foreign equivalent) degree preferred.
• Prior Clinical research experience in early phase drug development.
• Knowledge of Federal and local regulations.
• CITI.
• IATA.