• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $70,000 - $80,000

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 ("P&S") at Columbia University Irving Medical Center ("CUIMC"), the Regulatory Science Specialist assists the Associate Director in overseeing the CTO's regulatory compliance and providing assistance to the research community in the development and conduct of clinical trials.

The CTO, which is operated jointly with the New York-Presbyterian Hospital ("NYPH") assists investigators and academic/research staff in developing clinical trials at CUIMC and provides administrative resources and infrastructure to build and sustain clinical trials research.

Responsibilities

The Regulatory Science Specialist is responsible for the following:

• Collaborates with the Associate Director, the Executive Director of the CTO (the "Director"), the Medical Director of the CTO, CUIMC faculty and administration and 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, the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services and the rules of the Joint Commission.
• Assists the Medical Director and Associate Director of Regulatory Science in implementing the IND/IDE Assistance Program, which provides regulatory guidance in connection with investigator initiated clinical trials.
• Assists in the implementation of a training 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
• Provides assistance and support in creating and maintaining www.ClinicalTrials.gov records in compliance with applicable regulations and policies.
• Participates in the Clinical Trials Monitoring Assistance Program (CTMAP) that includes 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 such as programs to increase patient recruitment and to address regulatory and compliance needs.
• Provides support of RecruitMe Platform for the CUIMC research community including:
• Coordinating with investigators and research teams in RecruitMe entry.
• Developing training and process improvement projects, and other project management duties with RecruitMe.
• Collaborating with the Director and Associate Director to implement objectives and workflow strategies for content maintenance on RecruitMe and other CTO websites.
• Fulfilling reporting requirements for management, including metrics from Google Analytics data.
• Monitoring external communications for social media websites.
• Liaising with RecruitMe contacts, information technology ("IT") groups, CTSA leadership, outside vendors and/or internal partners in research for needs related to RecruitMe and other CTO websites.
• Represents the Manager and Director in his/her absence and all other duties as assigned.
  
  

Minimum Qualifications

• Bachelor's degree
• At least 4 years of experience in conducting clinical research

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:
• Particular 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
• Strong computer skills required, including proficiency with content management systems, social media websites, Microsoft Office
• 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.