The Assistant Director for Regulatory Affairs is an integral member of the senior leadership team within the Clinical Protocol & Data Management (CPDM) Office of the Herbert Irving Comprehensive Cancer Center (HICCC). The CPDM is a clinical resource of the HICCC that assists investigators and academic/research staff in developing oncology clinical trials and provides administrative resources and infrastructure to build and sustain investigator initiated, industry, and federally sponsored clinical research at the HICCC of P&S.
In this role, the Assistant Director for Regulatory Affairs is responsible for the development and implementation of an innovative program for Investigator-Initiated Oncology Clinical Trials as well as the day-to-day operations of the Regulatory core. Along with other members of the leadership team, the Assistant Director will assist the development of standards and guidance in order to maintain compliant and efficient clinical trials operations. This position reports directly to the Director of Clinical Research Operations.
Develop and implement effective methods for contributing to the design and development of Investigator-Initiated clinical research trials.
Development, implementation, and oversight of IND/IDE processes for all applicable Cancer Center trials.
Overseeing the Regulatory core whose responsibilities include IRB submission process for new and continuing trials, informed consent development, Financial Disclosures process on all protocols; regulatory binder maintenance, protocol modifications and internal and external audits of regulatory documents of protocols on a regular basis.
Overseeing the Compliance core whose responsibilities include central registration processes, including eligibility review, internal monitoring activities per our National Cancer Institute (NCI) Data and Safety Monitoring Plan (DSMP) and reporting findings to Cancer Center investigators, the Data and Safety Monitoring Committee (DSMC), CUMC Institutional Review Board (IRB), and CPDM leadership, as appropriate, Site audit preparation, including development, submission, and implementation of all corrective and preventative action plans to ensure research integrity and subject safety.
Oversees multi-center trials program including all sub-site management, auditing/monitoring, specimen collection, budget negotiations invoicing/payments and research fund accounting.
Monitor service center charge-back models for regulatory, multi-center and compliance cores, working closely with CPDM Senior Financial Analyst and Director of Clinical Research Operations.
Directly supervises the DSMC/PRMC manager, Multi-center manager, Regulatory manager, Compliance Core and indirect staff reports of the Regulatory and Multi-center coordinators.
Plan, assign, and review work of staff to ensure that group objectives are met.
Hire, train, develop, and manage staff to ensure that a qualified staff exists to meet group objectives.
Prepares reports for CPDM Director of Clinical Research Operations and Medical Director as requested.
Establishes and maintains standard operating procedures and guidelines for regulatory, compliance and multi-center practices as well as collaboration for the CPDM office.
Oversee ClinicalTrials.gov registrations for all HICCC Investigator Initiated Trials, including updates and final results reporting.
Other duties as assigned.
Bachelor's degree or equivalent in education and experience plus 5 years of related experience.
ACRP and/or SoCRA certification preferred.
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.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 504660
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.