Regulatory Affairs Analyst II – Clinical Trials

University of Miami; Miami (FL); On-site; USD 65,000 - 90,000; Full time

Job summary

The University of Miami UHealth Department of SCCC is hiring a Full Time Regulatory Analyst 2 to support regulatory submissions for clinical studies at the Miami, FL campus. The role oversees IRB coordination, maintains regulatory binders, and ensures compliance with FDA, NIH, and institutional SOPs while collaborating with investigators and study staff across departments.

Applicants should have a bachelor’s degree, CCRP if applicable, and at least two years of experience in regulatory affairs

Qualifications

• Bachelor’s degree in relevant field.
• CCRP certification, if applicable.
• Minimum 2 years of relevant experience.
• Knowledge of applicable federal, state, and local regulations.
• Knowledge of clinical trials procedures.
• Detail-oriented with accuracy.
• Strong written and oral communication skills.
• Ability to handle stressful situations professionally.
• Ability to work well with diverse teams.
• Ability to understand and follow instructions.

Responsibilities

• Oversee and support study submissions and regulatory document maintenance.
• Submit institutional clinical trial applications.
• Prepare decision correspondence and information requests.
• Assist with drafting and presenting programs to investigators and staff.
• Maintain knowledge of SOPs and regulatory requirements.
• Ensure regulatory processes comply with SOPs, FDA, NIH regulations.
• Maintain regulatory binders and DOAL; train staff.
• Communicate with coordinators and PIs to address deviations.

Skills

Regulatory submissions

IRB coordination

Document control

Compliance knowledge

Communication skills

Education

Bachelor’s degree in relevant field

CCRP certification

Job description

The University of Miami UHealth Department of SCCC is hiring a Full Time Regulatory Analyst 2 to support regulatory submissions for clinical studies at the Miami, FL campus. The role oversees IRB coordination, maintains regulatory binders, and ensures compliance with FDA, NIH, and institutional SOPs while collaborating with investigators and study staff across departments.

Applicants should have a bachelor’s degree, CCRP if applicable, and at least two years of experience in regulatory affairs