Clinical Research Regulatory Specialist (experience in submissions to IRB)

Job Description

Salary:

• MUST HAVE EXPERIENCE SUBMITTING TO IRB**
• MUST BE FULLY BILINGUAL - SPANISH** due to population served
  
  

(if you have no experience in IRB please do not apply)

Role Description

This is a full-time on-site role for a Regulatory Specialist at D&H National Research Centers located in Doral, FL. The Regulatory Specialist will be responsible for ensuring regulatory compliance and keeping current with regulatory requirements. The Regulatory Specialist will also be responsible for using analytical skills to interpret complex regulations, communicating regulatory changes to stakeholders, and overseeing regulatory affairs.

Duties:

• Conduct research and analysis to ensure compliance with regulatory requirements
• Manage compliance activities, including the development and implementation of policies and procedures
• Prepare and Coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study activation to study closure
• Review documentation for accuracy and completeness
• Maintain data management systems to track and report on regulatory activities
• Collaborate with cross-functional teams to ensure regulatory compliance
• Stay up-to-date with changes in regulations and communicate updates to relevant stakeholders
  
  

Requirements:

• Medical experience in related field (e.g., healthcare, life sciences)
• Experience in regulatory affairs or a related field
• Knowledge of Good Clinical Practice (GCP) guidelines and regulations
• Familiarity with clinical laboratory operations and medical terminology
• Proficiency in statistical software for data analysis
• Strong attention to detail and analytical skills
• Excellent communication and interpersonal skills
• Fluent in Spansh.
  
  

Note: This job description is intended to provide a general overview of the position. It is not an exhaustive list of all responsibilities, duties, and skills required.

Job Type: Full-time

Benefits:

• Paid time off
  
  

Experience level:

• 2 year
  
  

Schedule:

• Monday to Friday
  
  

Work Location: In person

Salary: $46,000 - $47,500 per year

Language:

• Spanish (Required)