Clinical Research Program Director

Program Director – Early Phase Clinical Research

The Program Director leads training and onboarding for new study coordinators and oversees the operational and financial aspects of an early phase clinical research program within an NCI-designated cancer center environment. This role manages a portfolio of clinical trials, ensures timely protocol start-up, maintains billing compliance, and serves as a primary liaison with external sponsors and regulatory bodies.

• Lead the training and onboarding of new study coordinators, ensuring they understand clinical trial protocols, regulatory requirements, and operational workflows.
• Work closely with the research team, including program leaders, co-investigators, research coordinators, research nurses, data managers, and protocol office staff, to manage each patient accrued to a study.
• Oversee billing compliance for Early Phase Therapeutics trials, ensuring proper ordering and association of consult and ancillary services such as laboratory tests and imaging.
• Review charges and designations after each visit is closed to confirm accuracy and compliance with billing guidelines.
• Manage the clinical trials portfolio and drive timely start-up of protocols to meet NCI expectations of less than 90 days from activation to initiation.
• Review Medicare coverage analyses to ensure appropriate procedure-level designations and alignment with regulatory and payer requirements.
• Serve as the principal liaison for the Early Phase Therapeutics clinical research program with pharmaceutical and biotechnology companies, fostering strong sponsor relationships.
• Coordinate and prepare for NIH, BRANY, and sponsor audits, as well as FDA inspections, including organizing documentation and supporting on-site review activities.
• Participate in departmental and institutional committees as needed, contributing expertise in clinical research operations and compliance.
• Perform other duties as assigned to support the overall success and growth of the clinical research program.

• At least 5 years of related work experience in clinical research or clinical operations, preferably in early phase drug development.
• Demonstrated experience in clinical research and clinical operations, including oversight of study conduct and coordination.
• Proven ability to onboard and train new staff, particularly study coordinators and clinical research personnel.
• Prior clinical research experience specifically in early phase drug development.
• Strong knowledge of federal and local regulations governing clinical research and clinical trials.
• Ability to manage a clinical trials portfolio and drive timely protocol start-up to meet defined time frames.
• Experience ensuring billing compliance for clinical trials, including proper ordering and association of consult and ancillary services.
• Skill in reviewing Medicare coverage analysis and understanding procedure-level designations.
• Commitment to obtaining ACRP or SOCRA certification within 24 months of employment.
• Current or prior completion of CITI training for human subjects research.
• Knowledge of IATA requirements related to the transport of biological specimens and materials.

• Advanced medical degree (MD or foreign equivalent) preferred, reflecting strong clinical and scientific background.
• Experience working in an NCI-designated cancer center or similar oncology-focused research environment.
• Familiarity with early phase therapeutics and complex oncology clinical trial designs.
• Strong interpersonal and communication skills to collaborate effectively with multidisciplinary research teams and external sponsors.
• Ability to represent the clinical research program as a principal liaison with pharmaceutical and biotechnology companies.
• Experience participating in or preparing for regulatory audits and inspections by organizations such as NIH, BRANY, sponsors, and the FDA.
• Demonstrated leadership capabilities in overseeing clinical research staff and guiding program operations.

The Program Director works within an NCI-designated cancer center that is highly focused on early phase clinical research and drug development.…