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Description

Job Summary

The Clinical Research Quality Coordinator ensures research compliance of NCH study regulatory submissions, including AAHRPP, FDA, IATA, Citi Training and GCP/ICH. Serves as a subject-matter expert for the research team on relevant laws, regulations, and best practices. Ensures quality goals, including accuracy and timeliness of documentation completion and/or submission are achieved. Monitors internal/external audits independently or with minimal supervision.

Job Specific Duties

• Ensure research compliance at NCH study regulatory submissions, including AAHRPP, FDA, IATA, Citi Training and GCP/ICH. 
  
• Serve as a subject-matter expert for the research team on relevant laws, regulations and best practices.
  
• Responsible for all aspects of study monitoring including routine monitoring and close-out. 
  
• Conducts routine facility visits and builds rapport with clinical and research staff. 
  
• Ensures quality goals, including correctness, accuracy and timeliness of documentation completion and/or submission are achieved. 
  
• Provides compliance direction and ensures NCH research policies and SOPs are harmonized with relevant rules, regulations, quality standards and good clinical practices. 
  
• Monitors internal and external research environment and coordinates the translation of new legislation and regulatory requirements into practice at NCH. 
  
• Routine monitoring of ICF's, data integrity, EMR's, and regulatory documents for completeness, accuracy, and compliance. 
  
• Ensure staff maintain protocol compliance and proper steps to ensure patient safety. 
  
• Analyze monitoring findings and assign major/minor violations, rating the findings, and completing a final monitoring report, including CAPA's for review and approval. 
  
• Assembles and provides process improvement based on monitoring findings as applicable. 
  
• Collects, maintains and reports data on regulatory and clinical compliance as required.

Qualifications

Minimum Job Requirements

• Bachelor's Degree BSN, Bachelor in Sciences or Education
  
• ACRP - Assc Cln Research Professional ACPR, SOCRA or Healthcare Research
  
• 1-3 years Clinical Research and/or monitoring or auditing.

Knowledge, Skills, and Abilities

• Knowledge of rules and regulations governing research.
  
• Knowledge in the human subject research including GCP and all applicable regulations.
  
• Experience in early phase and medical device experience a plus.
  
• 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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