Fast Affordable Solutions

Fast Affordable Solutions provides virtual staffing solutions that connect businesses, startups, and executives with highly skilled, English-speaking professionals, streamlining the hiring process to be fast, affordable, and efficient while also offeri...

Professional Services

Industrials

Founded 2021

6 open positions

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Regulatory Specialist – Study Start-Up

1 hour, 49 minutes ago

Mexico

Full-time

Junior

Operations Specialist

Operations

GCP HIPAA

Apply Now

Fast Affordable Solutions

Professional Services

Founded 2021

View All Jobs 6

Description

Prepare, compile, and submit regulatory documents to IRBs/ECs.
Support study start-up activities, including vendor access and regulatory collection.
Prepare documentation for SSVs, PSVs, and SIVs.
Support migration from Complion to Florence eRegulatory.
Perform data entry, document cleanup, and quality control during migration.
Create and organize eISFs in Florence.
Ensure documents are audit-ready and accurately filed.
Prepare FDA 1572s, FDFs, PSPs, and IB acknowledgments.
Route documents for signatures and follow up to completion.
Maintain CVs, licenses, and GCP documentation.
Partner with coordinators, investigators, and sponsors to track timelines and resolve delays.

Requirements

2+ years of clinical research regulatory experience required.
Knowledge of ICH/GCP, FDA regulations, and HIPAA.
Experience with eRegulatory systems, with Florence preferred.
Strong attention to detail and organization.
Ability to manage multiple timelines.
Strong communication skills.
High school diploma required; bachelor's degree preferred.
Florence eRegulatory experience preferred.
Current GCP certification preferred.

Benefits

Flexible, remote-friendly work environment.
Opportunity to grow into a full-time role and expand responsibilities.
Exposure to global clinical research operations and technology.
Hands-on experience with leading platforms such as Florence eRegulatory.
Collaborative, high-growth, and entrepreneurial environment.
Ongoing professional development and training opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

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