- Job Type: Officer of Administration
- Bargaining Unit:
- Regular/Temporary: Regular
- End Date if Temporary:
- Hours Per Week: 35
- Standard Work Schedule:
- Building:
- Salary Range: 130,000 - 140,000
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Position Summary
The Assistant Director for Regulatory Affairs, Quality, and Cancer Center Committees is a key member of the senior leadership team within the Clinical Protocol & Data Management (CPDM) Office at the Herbert Irving Comprehensive Cancer Center (HICCC). In this role, the Assistant Director is responsible for strategic planning, operational oversight, and quality improvement in regulatory affairs and Cancer Center committee operations. A major focus of this position is to decrease time to activation by streamlining workflows and collaborating with sponsors to improve transparency and trial start-up efficiency.
The Assistant Director also manages the development and tracking of Standard Operating Procedures (SOPs) and guidance documents, ensuring standardized, audit-ready processes across regulatory and quality operations. This individual will work closely with the Research Manager, Quality Assurance and Safety, to oversee monitoring assignments for investigator-initiated trials (IITs) and ensure timely reporting of findings and corrective actions. T
The Assistant Director reports directly to the Director of Clinical Research Operations and partners closely with the CPDM senior leadership, and investigators to ensure safe, efficient, and compliant execution of clinical research.
This position is located at 400 Kelby St. Fort Lee, NJ.
Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.
Responsibilities
The Assistant Director, Regulatory Affairs along with the respective managers of each group oversees the day-to-day activities of regulatory, DSMC, PRMC, Quality and multicenter trial cores within each respective group.
Responsibilities include, but are not limited to:
Leadership & Oversight
- Provide leadership for regulatory affairs, quality initiatives, and Cancer Center committees, aligning all functions with institutional and NCI standards.
- Guide and collaborate with managers to oversee day-to-day operations of the following areas:
- Regulatory Core
- Quality Core
- Data and Safety Monitoring Committee (DSMC)
- Protocol Review and Monitoring Committee (PRMC)
- Supervise direct reports including regulatory, quality, DSMC/PRMC managers, and provide indirect oversight of their respective teams.
- Recruit, hire, train, and mentor staff to develop a high-performing team that supports the Cancer Center’s clinical research mission.
- Meets regularly with direct reports.
- Perform Performance appraisals
- Provides counseling or performance improvement plans as needed.
- Manages tracking of time and attendance.
- Manages and evaluates employees’ orientation and ongoing training.
- Foster a culture of innovation, collaboration, and accountability focused on continuous improvement and operational excellence.
Regulatory Oversight
- Lead the development and implementation of efficient regulatory workflows to accelerate trial activation and reduce administrative bottlenecks.
- Oversee IND/IDE submissions and maintenance for applicable Cancer Center trials.
- Supervise all IRB-related activities, including:
- Initial and continuing reviews
- Informed consent creation and revision
- Financial disclosure tracking and reporting
- Tracking of amendments and modifications
- Regulatory binder creation and maintenance
- Implement proactive internal audit processes to identify and address compliance risks before they impact trial activation or continuation.
- Work closely with investigators and study teams to ensure audit readiness and complete, compliant documentation for all trials.
Quality Management
- Provide strategic leadership for the Quality Core, promoting excellence in trial conduct, data integrity, and subject safety.
- Oversee central registration and eligibility verification processes to ensure accuracy and compliance.
- Develop and manage quality performance metrics, with an emphasis on decreasing time to activation, review turnaround, and audit readiness.
- Collaboration with the Research Manager, Quality Assurance and Safety to:
- Assign monitoring responsibilities for IITs.
- Ensure that monitoring is conducted according to the NCI Data and Safety Monitoring Plan (DSMP).
- Track monitoring activities and reporting timelines.
- Review monitoring reports and findings.
- Oversee development and implementation of Corrective and Preventive Action Plans (CAPAs) to resolve identified issues and enhance trial quality.
- Prepare for external audits and inspections by ensuring comprehensive, well-documented quality systems are in place.
- Partner with stakeholders to implement systemic changes based on quality review outcomes and audit findings.
Sponsor Collaboration & External Engagement
- Build strong relationships with sponsors, CROs, and regulatory partners to:
- Improve communication on trial start-up requirements and expectations.
- Address operational barriers that delay activation or amendment approvals.
- Develop standardized workflows for faster site readiness and trial launch.
- Participate in joint planning sessions with sponsors to reduce activation timelines and enhance trial collaboration.
- Represent CPDM in sponsor discussions to advocate for institutional needs and process improvements.
Cancer Center Committees
- Provide strategic oversight for key Cancer Center committees, including:
- DSMC (Data and Safety Monitoring Committee): ensuring trial safety, data integrity, and quality oversight.
- PRMC (Protocol Review and Monitoring Committee): evaluating scientific merit, prioritization, and feasibility of protocols.
- Optimize committee workflows to reduce delays in protocol approval and review turnaround times.
- Assign reviews, track completion, and maintain thorough documentation of outcomes.
- Prepare and distribute agendas, minutes, and summary reports for leadership review.
Standard Operating Procedures (SOPs) & Guidance Documents
- Lead the development, implementation, and tracking of SOPs and guidance documents for regulatory, quality, and committee operations.
- Assign SOP review and update responsibilities to staff and committee members, ensuring accountability and timeliness.
- Maintain tracking systems for SOP lifecycle management, including drafting, approval, and version control.
- Conduct internal audits to ensure adherence to SOPs and identify opportunities for process improvement.
- Align SOP content with time-to-activation goals and best practices to enhance efficiency.
Financial & Resource Management
- Partner with the CPDM Finance Managers and Director of Clinical Research Operations to:
- Monitor resources and staffing for regulatory and quality functions.
- Provide input into charge-back models for sustainability and transparency.
- Ensure efficient use of resources to support faster trial activation and quality oversight.
- Provides monthly activity reports for billing
ClinicalTrials.gov & Trial Registration
- Oversee ClinicalTrials.gov registrations for all HICCC investigator-initiated trials.
- Ensure compliance with federal registration and reporting requirements.
- Implement tracking systems to prevent delays in trial registration, updates, or reporting.
Reporting & Metrics
- Develop and distribute reports for CPDM leadership, including:
- Time-to-activation performance metrics by trial type.
- DSMC and PRMC committee review statistics.
- IIT monitoring outcomes and follow-up actions.
- Quality performance dashboards and improvement initiatives.
- Sponsor collaboration updates and external partnership metrics.
Other Duties
- Represent CPDM on institutional and external committees related to quality, regulatory affairs, and clinical trial activation.
- Act as a subject matter expert for oncology clinical trial regulatory and quality practices.
- Lead special projects and additional assignments as requested by the Director of Clinical Research Operations.
- Perform other related duties and responsibilities as assigned/requested.
Minimum Qualifications
- Bachelor’s degree or equivalent in education and experience plus 5 years of related experience.
Preferred Qualifications
- At least four years supervisory experience in clinical trials.
- Must have worked in a clinical research setting and have experience working with Federal Regulations and IRBs required; experience with oncology research protocols.
- In depth knowledge of federal, state and local laws and regulations and industry requirements and practices regarding the proper conduct of clinical trials.
- Particular knowledge and experience in FDA matters, including regulations relating to INDs and IDEs.
- Expert working knowledge in ICH-GCP, patient safety standards, and IRB regulations pertinent to clinical research.
- Excellent verbal and written communication skills.
- Excellent interpersonal and presentation skills.
- Computer Skills: proficiency with MS Word programs and familiarity with Mac and PC platforms
- Proven ability to collaborate with partners in research, investigators and coordinators.
- ACRP and/or SoCRA certification preferred.
- Master’s degree.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
