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 malignant hematology oncology clinical research program. Expansion of the Malignant Hematology 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 hematologic malignancy 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 hematologic malignancy clinical research program principal liaison with pharmaceutical and biotechnology 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.
