Clinical Research Regulatory Specialist (experience in submissions to IRB)

Job Description

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)