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 (Program Leaders, 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/Qualifications

Master's degree in Life Science or Public Health required

5 year's 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