Job Description
City/State:
Bronx, New York
Grant Funded:
Yes
Department:
Cancer Clinical Trials Office - Operations
Work Shift:
Day
Work Days:
MON-FRI
Scheduled Hours:
9 AM-5 PM
Scheduled Daily Hours:
7.5 HOURS
Pay Range:
$168,000.00-$210,000.00
The Chief Physician Assistant leads the Phase 1 (early phase) oncology clinical trials program at Montefiore Einstein Comprehensive Cancer Center, an NCI-designated comprehensive cancer center. The role combines program leadership with direct care of patients enrolled on first-in-human and early phase trials.
The Chief PA oversees the program's clinical and research operations: advanced practice providers, clinical research staff, the trial portfolio, sponsor and CRO relationships, and quality. The Chief PA works closely with Phase 1 investigators, research nursing, investigational pharmacy, regulatory affairs, and CCTO leadership.
We are looking for an experienced, committed clinician and leader who can grow a high-performing Phase 1 program and expand access to novel therapies for the diverse patient population of the Bronx.
Program leadership and administration
- Lead daily operations of the Phase 1 program across clinic, infusion, and research functions to ensure safe, efficient enrollment and treatment of trial participants
- Supervise Phase 1 advanced practice providers and research staff (clinical trial managers, research associates), directly or through managers: hiring, onboarding, scheduling, performance evaluations, and professional development
- Manage the Phase 1 trial portfolio with the Phase 1 Physician Leader: feasibility review, study selection, prioritization, and capacity planning
- Oversee study start-up and activation in partnership with Regulatory Affairs, including site qualification visits and site initiation visits
- Manage cohort slot allocation, screening pipelines, and enrollment against sponsor timelines and accrual goals
- Serve as the primary operational contact for sponsors and CROs; lead escalation of site performance issues and monitoring findings.
- Develop and monitor staffing models, and accrual and productivity metrics; report to CCTO and Cancer Center leadership
- Coordinate with investigational pharmacy, research nursing, specimen processing, radiology, and Epic Beacon teams to maintain efficient trial workflows
- Lead Phase 1 team meetings and participate in dose escalation safety reviews and CCTO leadership meetings
APP leadership and clinical oversight
- Provide clinical leadership and supervision of Phase 1 advanced practice providers (PAs and NPs)
- Set clinical standards for eligibility assessment, adverse event assessment and grading (CTCAE), dose-limiting toxicity evaluation, and protocol-required documentation
- Develop and implement Phase 1 clinical workflows and pathways, including management of infusion reactions, cytokine release syndrome, and other early phase toxicities
- Monitor clinical quality, patient safety events, and protocol compliance; lead corrective and preventive actions
- Serve as liaison between APPs, investigators, nursing, pharmacy, and administrative leadership
Clinical responsibilities
- Under guidance of a supervising MD, maintain a clinical panel of patients enrolled on early phase trials: review histories, perform physical exams and review of systems, and manage treatment and supportive care
- Screen patients for trial eligibility in collaboration with investigators and research staff
- Explain study participation to patients and families, including treatment options, alternatives, and expected and unexpected side effects; participate in the informed consent process as delegated by the Principal Investigator
- Assess, grade, attribute, and manage adverse events within scope of practice and protocol requirements
- Write medical orders for RNs and staff to carry out; ensure protocol-required assessments (labs, PK samples, ECGs, imaging) are ordered and completed in Epic Beacon
- Document patient care in the EHR in a timely, protocol-compliant manner that supports source documentation and monitoring
- Respond to urgent clinical issues and emergencies in the clinic and treatment areas
Research billing and sponsor invoicing
- Accountable for the Epic research billing review for all Phase 1 study activity, ensuring charges route to the study or to insurance per the coverage analysis; performs reviews directly or oversees the clinical trial managers who complete them
- Accountable for timely, accurate invoicing of sponsor-billable charges (e.g., procedures, screen failures, pass-through costs) through the CCTO's external invoicing partner, including reconciling invoices against study activity and resolving discrepancies
- Monitors billing review timeliness and error trends, and corrects workflows or retrains staff as needed
Quality, compliance and audit readiness
- Ensure the program complies with ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 56 and 312), IRB requirements, protocols, and institutional policy
- Maintain readiness for sponsor audits, NCI and cooperative group audits, and FDA inspections; lead site responses to monitoring findings and protocol deviations
- Ensure research billing practices comply with the Medicare Clinical Trial Policy and institutional billing compliance requirements
Education and program development
- Develop and maintain orientation, training, and competency programs for Phase 1 APPs and research staff
- Mentor APPs, research staff, and trainees, and support their continuing education
- Lead process improvement initiatives to shorten study activation timelines and improve enrollment
- Participate in CCTO and Cancer Center initiatives, quality improvement efforts, and scholarly activities
Qualifications
Required
- Master's degree in Physician Assistant Studies from an accredited program
- Current certification by the National Commission on Certification of Physician Assistants (NCCPA)
- Active New York State Physician Assistant license and registration
- Minimum of 5 years of clinical experience as a PA, including at least 3 years in hematology/oncology
- Experience caring for patients enrolled on oncology clinical trials
- Prior leadership, supervisory, or program management experience
- Working knowledge of ICH-GCP, FDA regulations, and IRB requirements for human subjects research
- Strong clinical judgment, organizational, and communication skills
- Current BLS certification; OHS fit test and annual assessment
Preferred
- Experience in a dedicated Phase 1 or early phase oncology program, including first-in-human, dose escalation, and PK-intensive studies
- Experience with novel therapeutic modalities such as T-cell engagers, antibody-drug conjugates, or cell therapies
- Experience with trial feasibility, and sponsor or CRO management
- Proficiency with Epic, including Beacon
- ACLS certification
- SOCRA or ACRP research certification
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.
Numbers & Facts
| Location | Bronx, NY |
| Industry | Healthcare Services |
| Salary | $168,000–$210,000 Per Year |
| Company Size | 10,000 employees or more |
| Website | http://www.montefiore.org/ |
About Company
About Montefiore Medical Center
Commitment to Excellence
As the academic medical center and University Hospital for Albert Einstein College of Medicine, Montefiore Medical Center is nationally recognized for clinical excellence—breaking new ground in research, training the next generation of healthcare leaders, and delivering science-driven, patient-centered care.
Montefiore is ranked among the top hospitals nationally and regionally by U.S. News & World Report. For more than 100 years we have been innovating new treatments, new procedures and new approaches to patient care, producing stellar outcomes and raising the bar for medical centers in the region and around the world. As we build on this momentum, we continue to advance the practice of medicine and set the standard for excellence.
Enduring Mission and Distinguished History
The mission of Montefiore is to heal, to teach, to discover and to advance the health of the communities we serve.
From its beginning in 1884, as a facility for the care of patients with tuberculosis and other chronic illnesses, to the new millennium, Montefiore has been at the forefront of patient care, research and education and steadfast commitment to its community.
Our Services
We provide coordinated, compassionate and leading-edge care designed to reach people when and where they need it most. Through highly integrated teams of physicians, nurses, social workers, mental health professionals and other caregivers, we have created an innovative, seamless system of care focused around the patient.
Notable Centers of Excellence
At the intersection of Einstein science and Montefiore medicine is our commitment to scientific inquiry. This commitment has resulted in the creation of the Montefiore-Einstein Centers of Excellence in cancer care, cardiovascular services, transplantation and children’s health, where nationally recognized investigators and multidisciplinary clinical teams collaborate to develop and deliver advanced, innovative care.
Advanced Specialty and Surgical Care
We offer advanced, multidisciplinary care across specialties, delivering one standard of excellence for all. Our interventions are designed to help patients understand and manage their illness, advocate for their health, access the right treatments and receive the vital social support they need to flourish. On multiple fronts, Montefiore is developing more effective and less invasive approaches to complex problems from procedures to repair diseased hearts, protocols to treat complex cancers and medical devices designed to meet the needs of growing children.
Primary Care
With nearly 50 primary care locations throughout the New York metropolitan area, we are focusing on accessible, patient-centered primary and preventive care provided by leading physicians in the areas of family and internal medicine, pediatrics, obstetrics and gynecology, and a team of experts in nursing, health education, nutrition and pharmacy.
Providing Care Without Walls
Montefiore combines its deep commitment to the community with nationally-renowned expertise to reach people in locations easiest for them. Through Montefiore’s School Health Program (MSHP), Primary Care at Home programs, mobile medical and dental health vans and health education initiatives, Montefiore provides primary care services in non-traditional settings.
Through the formation of highly integrated teams of physicians, nurses, social workers, mental health professionals, care managers and other caregivers, we provide care around the patient, when and where they need it.
Research and Education
Montefiore's partnership with Einstein advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Together, the two institutions are among 38 academic medical centers nationwide to be awarded a prestigious Clinical and Translational Science Award (CTSA) by the National Institutes of Health.
The second-largest medical residency program in the country, with 1,251 residents and fellows across 89 programs, Montefiore provides the doctors of tomorrow a unique opportunity for education and training in one of the most diverse urban areas in the country — one where the population is global, the disease burden is high, and the need for quality care is great.
The partnership is further strengthened by the dual appointments of faculty and physicians across both organizations—enhancing synergies and collaborations for research, teaching and patient care.
Comprehensive Care Management
Since 1996, Montefiore has developed advanced models of care management to help patients, especially those with chronic diseases such as diabetes, heart failure and mental illness, achieve better health and improved wellbeing in a cost effective way. Montefiore goes beyond fragmented fee-for-service payments, assuming total responsibility for the quality and costs of care for some of our sickest patients.
Through CMO, Montefiore Care Management, we use a global prepayment or similar strategies to manage care for 200,000 individuals over the continuum, including hospital care, rehabilitation, outpatient care, professional services, home care, mental health counseling, community-based services, remote patient monitoring and many other programs.
Our leadership in coordinating care across multiple settings has earned us federal recognition from the Centers for Medicare and Medicaid Services as a Pioneer Accountable Care Organization. Montefiore's ACO is one of only 32 organizations in the nation, as well as the only one in New York State, to operate under this new model of providing Medicare beneficiaries with higher quality care, while reducing expenditures through enhanced care coordination.
Learn More
- Mission, Vision and Values – Montefiore’s unique path of growth into the future and the clinical excellence and outstanding customer care that will get us there.
- History and Milestones – Proud traditions guiding our mission and the moments that helped shape Montefiore into a premier academic medical center.
- Commitment to the Community – Community health, education and neighborhood development.
- Leadership – Executives and clinical chairs leading Montefiore’s advancements.
- Physicians – Widely acclaimed medical professionals and specialists who provide our patients with the highest standards of care.
- Nursing Staff – Highly competent and compassionate professionals committed to improving the health of their patients.
- Ways to Give – Philanthropic opportunities and other ways to support Montefiore Medical Center.
Skills
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