PROGRAM DIRECTOR CCTO (JR227774)

Introduction

To heal, to teach, to discover and to advance the health of the communities we serve.

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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.

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