Regulatory Science Specialist

Responsibilities

• Collaborates with the Associate Director, the Executive Director of the CTO, 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.
• Fulfills reporting requirements for management, including metrics from Google Analytics data.
• Maintains monitoring external communications for social media websites.
• Represents the Manager and Director in his/her absence and all other duties as assigned.

Qualifications

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