Regulatory Affairs Assistant — Clinical Research Start-Up

QPS Holdings, LLC; Miami (FL); On-site; USD 50,000 - 65,000; Full time

Benefits offered by this job

Learning and development opportunities

Bonuses and merit increases

Wide range of benefits including 401(k

Job summary

QPS Holdings, LLC in Miami, FL is seeking a Regulatory Affairs Assistant responsible for preparing, organizing, submitting, and maintaining regulatory documents for clinical studies. You will ensure records are complete, accurate and compliant with GCP, IRB, sponsor, and company requirements, coordinating with multiple internal teams.

The role supports start-up, ongoing maintenance, and closeout activities, maintaining binders and electronic files, and assisting with FDA forms, amendments, and

Qualifications

• Combination of relevant education & experience provides success in this role.
• High school diploma or equivalent required; Associate/Bachelor's preferred in life sciences, healthcare administration, regulatory affairs, business administration.

Responsibilities

• Assist with preparation, collection, review, and submission of regulatory documents to IRBs, sponsors, CROs, and other parties.
• Support regulatory activities for study start-up, including submissions, amendments, renewals, continuing reviews, and study closures.
• Maintain regulatory binders and electronic regulatory files across each clinical study lifecycle.
• Assist with FDA Form 1572, investigator agreements, delegation logs, protocol signatures, and related documents.
• Track document expiration dates and obtain updated licenses, certifications, and training records.
• Submit and distribute protocol amendments, revised consent forms, safety reports, and regulatory communications.
• File and provide access to approved protocol documents for study team.
• Maintain regulatory tracking logs, letters, correspondence, and version histories.
• Communicate missing documents, deadlines, signatures, and pending submissions with study personnel.
• Update credentials (CVs, licenses, GCP certificates) for Institutions, Investigators, Site Staff.
• Assist sponsor monitoring visits, internal audits, IRB reviews, and regulatory inspections.
• Respond to regulatory document requests and resolve filing discrepancies.
• Upload and maintain study documents in electronic systems and shared drives.
• Protect confidential information and ensure HIPAA compliance.

Skills

Regulatory knowledge

Documentation management

Attention to detail

Communication

Team collaboration

Education

High school diploma or equivalent

Associate or Bachelor's in life sciences/healthcare/regulatory affairs/business administration

Tools

Regulatory databases

Electronic Trial Management Systems (eTMF/CTMS)

Job description

QPS Holdings, LLC in Miami, FL is seeking a Regulatory Affairs Assistant responsible for preparing, organizing, submitting, and maintaining regulatory documents for clinical studies. You will ensure records are complete, accurate and compliant with GCP, IRB, sponsor, and company requirements, coordinating with multiple internal teams.

The role supports start-up, ongoing maintenance, and closeout activities, maintaining binders and electronic files, and assisting with FDA forms, amendments, and