Regulatory Affairs Assistant – Clinical Research

Job overview

The Regulatory Affairs Assistant – Clinical Research is an onsite, full-time role in Miami, FL; compensation is not specified. QPS provides clinical research services to pharmaceutical, biotechnology, and medical device companies, and its Miami site is a multispecialty research center. The assistant organizes and maintains regulatory documentation throughout clinical study lifecycles. The work supports timely study start-up, ongoing maintenance, and closeout while helping ensure records meet applicable regulations, Good Clinical Practice, IRB, sponsor, and company requirements.

What you'll do

• Prepare, collect, review, and submit regulatory documents to IRBs, sponsors, CROs, and other parties
• support study start-up, amendments, renewals, continuing reviews, and closures
• maintain regulatory binders and electronic files
• assist with FDA Form 1572 and related documents
• track expiration dates and obtain updated credentials
• maintain submission logs and document histories
• communicate about missing documents and deadlines
• support monitoring visits, audits, IRB reviews, and inspections
• upload study documents
• protect confidential information and comply with HIPAA and privacy requirements.

What we're looking for

Skills & competencies

regulatory affairs assistant

clinical research

full-time

miami fl

qps

regulatory documentation

clinical studies

irb submissions

good clinical practice

study start-up

hipaa

Work arrangement

• Weekend coverage required

Benefits & perks

• Company-matched 401(k)
• company-sponsored group life/AD&D and short- and long-term disability insurance
• learning opportunities, bonuses, and merit increases.

Why this role

High school diploma or equivalent required; an associate or bachelor’s degree in a related field is preferred. The posting highlights learning opportunities for people new to the field.

About the employer

QPS, LLC is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.