Regulatory Science Specialist

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $70,000 - $75,000

Position Summary

Reporting directly to the Associate Director of Regulatory Science (the "Associate Director") of the Clinical Trials Office (the "CTO") of Columbia University's Vagelos College of Physicians & Surgeons ("VP&S") at Columbia University Irving Medical Center ("CUIMC"), the Regulatory Science Specialist assists the Associate Director in overseeing the CTO's regulatory compliance program and providing assistance to the research community at VP&S in the development and conduct of clinical trials.

The CTO assists investigators and academic/research staff in developing clinical trials at VP&S and provides administrative resources and infrastructure to build and sustain clinical trials research at VP&S. 

Responsibilities

The Regulatory Science Specialist is responsible for the following:

• Collaborates with the Associate Director and the Executive Director of the CTO, as well as CUIMC faculty and administration and NewYork-Presbyterian Hospital (NYPH) administration in meeting the institutional needs regarding clinical trial compliance, quality assurance, training, and process-improvement goals.
• Assists the Associate Director in developing and implementing policies and procedures designed to assure that clinical trials are carried out in compliance with applicable federal and state regulations, including those promulgated in the U.S. Food and Drug Administration (FDA), the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services and the rules of the Joint Commission.
• Manages and oversees services to assist and support researchers with ClinicalTrials.gov registration and results reporting in compliance with applicable regulations and policies.
• Leads efforts with internal tracking for trial registration and reporting within the institution-wide Protocol Registration and Results System (PRS) organizational account.
• Oversees institution-wide notifications and communication with researchers for regulatory updates and actionable items related to trial reporting.
• Develops and maintains an institution-wide system for ClinicalTrials.gov tracking and metrics to prepare reports on compliance rates and related activities.
• Develops and conducts educational training related to ClinicalTrials.gov trial reporting to researchers and institutional leadership, as needed.
• Assists the Associate in implementing the IND/IDE Assistance Program, which provides regulatory guidance in connection with investigator initiated clinical trials conducted under Faculty-held IND/IDE applications, which can include assistance with preparing and reviewing application documents and required reporting, support with protocol design, and any other tasks that are necessary in maintaining an effective IND/IDE and complying with all applicable regulations and policies.
• Assists in the implementation of a program for research personnel, including research newsletters, workshops, and didactic training sessions upon request.
• Provides guidance regarding regulatory and institutional requirements to investigators and research personnel, inclusive of 1:1 training for investigators and research teams as requested.
• Participates in the Clinical Trials Monitoring Assistance Program (CTMAP) that includes collaborating with departments in implementation of their quality assurance monitoring programs and providing oversight and monitoring of investigator/coordinator compliance with standard operating procedures as they pertain to the conduct of FDA regulated clinical trials.
• Collaborates with the CTSA and the HRPO/IRB in developing programs to to address regulatory and compliance needs of trial registration and results reporting.
• Representing the Associate Director in his/her absence.
• Performs related duties & responsibilities as assigned/requested.

Minimum Qualifications

• Bachelor's degree or equivalence in education and experience plus 3 years of related experience.

Preferred Qualifications

• In depth knowledge of federal, state, and local laws and regulations and industry requirements and practices regarding the proper conduct of clinical trials:
• Knowledge and experience in FDA matters, including regulations relating to INDs and IDEs
• Expert working knowledge in GCP, patient safety standards and IRB regulations pertinent to clinical research.
• Demonstrable ability to collaborate with partners in research, investigators, and coordinators.
• Excellent verbal and written communication skills
• Excellent interpersonal and presentation skills
• Ability to manage/handle multiple tasks, teams, and teamwork simultaneously.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.