PROGRAM DIRECTOR CCTO

3000 Montefiore Medical Center; United States; On-site; USD 116,000 - 145,000; Full time

Job summary

Montefiore Medical Center in Bronx, NY invites applications for Program Director of the Early Phase Therapeutics oncology clinical research program. This role oversees daily operations across multiple campuses, manages data managers, research associates, and technicians, and drives financial growth and expansion of the program.

The successful candidate will hold a master's degree in Life Science or Public Health, have extensive clinical research experience in early phase drug development, and be

Qualifications

• Master's degree in Life Science or Public Health is required.
• MD, DDS (or foreign equivalent) degree preferred.
• CITI certification within 24 months of employment.
• IATA certification or training is required.

Responsibilities

• Training and on-boarding of new study coordinators.
• Work with the research team to manage each patient accrued to a study.
• Billing compliance for Early Phase Therapeutics trials, including services and charges.
• Manage clinical trials portfolio and ensure timely startup of protocols (< 90 days).
• Review Medicare coverage analysis for procedure designations.
• Liaise with pharmaceutical and biotech companies for the program.
• Prepare for NIH, BRANY and Sponsor audits and FDA inspections.
• Participate in departmental and institutional committees.
• Other duties as assigned.

Education

Master's degree in Life Science or Public Health

MD, DDS (or foreign equivalent)

CITI Certification

IATA Training

Job description

City/State: Bronx, New York Grant Funded: Yes Department: Cancer Clinical Trials Office Work Shift: Day Work Days: MON-FRI Scheduled Hours: 9 AM-5:30 PM Scheduled Daily Hours: 7.5 HOURS 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 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

CITI IATA 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 their 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.

Since its inception in 1884, Montefiore's mission has been to heal, to teach, to discover and advance the health of the communities we serve.

Montefiore's state-of-the-art facilities include the internationally-recognized Children's Hospital at Montefiore and our Notable Centers of Excellence - Montefiore Einstein Center for Cancer Care, Montefiore Einstein Center for Heart and Vascular Care, Montefiore Einstein Center for Transplantation.

Combined with a growing number of locations for primary and specialty care throughout the Bronx and Westchester County, Montefiore is the ideal organization to apply and hone your expertise.

An assortment of insurance products and discount programs through Voluntary Benefits.

Check out our comprehensive benefits available to you when you join our outstanding team!

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

To be a premier academic medical center that transforms health and enriches lives.

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