Columbia University Irving Medical Center · 5 hours ago
Regulatory Science Specialist
New York, NY
Full-time
Onsite
Mid Level
$70K/yr - $80K/yr
4+ years expColumbia University Irving Medical Center is a leading institution in clinical research, and they are seeking a Regulatory Science Specialist to assist in overseeing regulatory compliance and supporting the research community in clinical trials. The role involves collaboration with various stakeholders to ensure adherence to federal and state regulations and to implement training and process improvement initiatives.
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Responsibilities
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
Qualification
Required
Bachelor's degree
At least 4 years of experience in conducting clinical research
Preferred
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
Company
Columbia University Irving Medical Center
Columbia University Irving Medical Center is a clinical and educational enterprise that offers medical, dental, and nursing services. It is a sub-organization of Columbia University.
10001+ employees
H1B Sponsorship
Columbia University Irving Medical Center has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
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Trends of Total Sponsorships
2025 (334)
2024 (357)
2023 (338)
2022 (372)
2021 (283)
2020 (221)
Funding
Current Stage
Late StageLeadership Team
D
Donna Lynne
Senior Vice President and COO
Recent News
2025-10-17
2025-10-06
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