PROGRAM DIRECTOR CCTO - Montefiore Health System
Location: Bronx, New York
Department: Cancer Clinical Trials Office
Shift: Day
Schedule: MON-FRI, 9 AM-5:30 PM (7.5 HOURS daily)
Pay Range: $116,000.00-$145,000.00
The Program Director is responsible for the daily operations, financial growth, and expansion of the Early Phase Therapeutics oncology clinical research program. Expansion may include physical expansion across multiple campuses, development of a research-specific unit, and cultivation of relationships with key industry partners. The position will oversee operations across multiple campuses, supervising data managers, research associates, and technicians.
Responsibilities
* Training and onboarding of new study coordinators
* Collaborate with research team (program leaders, co-investigators, coordinators, nurses, data managers, protocol office staff) to manage patients accrued to a study
* Billing compliance of Early Phase Therapeutics trials, ensuring proper ordering and association of consult and ancillary services, reviewing charges and designations once visits are closed
* Manage clinical trials portfolio and assure 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 liaison with pharmaceutical and biotechology companies
* Prepare for NIH, BRANY, 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 years of 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 certification
* IATA training
Montefiore Medical Center is an equal employment opportunity employer. Montefiore Medical Center will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to 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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