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Description

Job Summary

Provides technical and subject-matter guidance on research regulatory affairs and training matters. Responsible for identifying regulatory research-related training requirements including, but not limited to, AAHRPP, governmental agencies, research sponsors GCP/ICH regulations and institution. Ensures training plans have met requirements and are approved. Ensures training performance of research personnel are tracked and reported. Ensures processes are in place and roles are defined for timely and accurate submission, tracking and communication of regulatory documents, avoiding delays or errors which can lead to regulatory or policy non-compliance.

Job Specific Duties

• Serve as a subject-matter expert for the research team on relevant laws, regulations, and best practices. 
  
• Sets priorities for the conduct of regulatory activity. 
  
• Actively participates in the day-to-day regulatory activity including submission of documents to WIRB or appropriate IRB. 
  
• Ensures quality goals, including correctness, accuracy and timeliness of documentation completion and/or submission are achieved. 
  
• Provides technical direction and ensures Nicklaus Children's Research policies and SOPs are harmonized with relevant rules, regulations, quality standards, and good clinical practices. 
  
• Monitors the external research environment and coordinates the translation of new legislation and regulatory requirements into practice at Nicklaus Children's. 
  
• Serves as a resource and as a technical expert for the development and delivery of research related training. 
  
• Establishes research training and education curricula to meet Nicklaus Children's needs. 
  
• Ensures required training is provided to NCH new and existing investigators and research staff including fellows and residents. 
  
• Assembles and maintains proper training documentation.
  
• Collects, maintains, and reports data on regulatory and training matters as required. 
  
• Provides guidance on study regulatory submissions, including AAHRPP, FDA, IATA, Citi Training and GCP/ICH.

Qualifications

Minimum Job Requirements

• Bachelor's of Nursing (BSN), Sciences, or Education (or) 5 years of relevant experience
• 4-7 years of experience in clinical research

Knowledge, Skills, and Abilities

• Assc Cln Research Professional ACRP or SOCRA, or Health Care Research
• Knowledge of rules and regulations governing research.
• Ability to transfer technical knowledge to others using a variety of tools and techniques.
• Ability to relate cooperatively and constructively with coworkers, potential and actual investigators and research staff.
• Ability to communicate effectively in English, both verbally and in writing.
• Ability to maintain confidentiality of sensitive information.
• Ability to set and effectively communicate priorities in a changing environment.
• Ability to respond calmly under stressful conditions.
• Ability to use complex mathematical techniques to budget and provide productivity assessments.
• Ability to use logical and scientific thinking to interpret technical data and solve a broad range of problems.

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