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Regulatory Coordinator — Clinical Research

Neutra Life Sciences
Houston, TX

Quick Apply

Job Details

Full-time
From $18 an hour

Benefits

Paid time off

Qualifications

Correspondence management
Document control experience within pharmaceutical industry
Operations coordination
FDA 21 CFR Part 11
ICH guidelines
Records management
Attention to detail
Staff training
Organizational skills
Regulatory submission editing and review
Ethical review application preparation
Delegation
Research compliance audit records management
Research compliance quality assurance records management

Full Job Description

The Regulatory Coordinator owns the full regulatory lifecycle of every study NLS conducts — from feasibility assessment through study close-out. This is a single point of accountability for IRB/IEC submissions, essential document maintenance, and regulatory correspondence across all active studies and sites. You will work closely with Clinical Operations, site coordinators, and principal investigators to keep every study in continuous, audit-ready regulatory compliance.

Key Responsibilities
Feasibility & Site Start-Up

Complete regulatory sections of sponsor feasibility questionnaires; assess site and PI regulatory readiness (active licensure, certifications, prior IRB history)
Coordinate collection of PI/sub-investigator CVs, medical licenses, and certifications required for IRB submission packages
Prepare and submit initial IRB/IEC packages: protocol, informed consent form (ICF), investigator's brochure, Form FDA 1572, financial disclosure forms, and recruitment materials
Track IRB correspondence to approval; confirm the approved ICF version matches the version in active use at site activation
Establish the regulatory binder/eISF structure for each new study
Build the initial Delegation of Authority (DOA) log, mapping delegated tasks to qualified, trained staff

Study Conduct

Submit continuing review/renewal packages ahead of IRB deadlines, with enough lead time to prevent any lapse in active approval
Process protocol amendments and ICF revisions through IRB submission and manage re-consent logistics for affected subjects
Submit safety reports (SAEs, IND safety reports, urgent safety measures) to the IRB within required timelines
Maintain the DOA log as staff changes occur, confirming training documentation supports each delegation
Track licensure, certification, and training expirations across site staff; flag upcoming lapses with adequate lead time for renewal
Maintain the regulatory binder/eISF in continuously audit-ready condition per ICH E6 essential document requirements; support monitor and sponsor regulatory reviews
Serve as the primary point of contact with the IRB and sponsor regulatory/CRA contacts for all submission correspondence

Study Close-Out

Prepare and submit final study reports and closure notifications to the IRB
Complete final reconciliation of the regulatory binder against the essential document checklist
Coordinate document archival per sponsor and regulatory retention requirements
Support close-out visit regulatory documentation review

Cross-Functional

Partner with Clinical Operations and site coordinators to confirm regulatory readiness gates are met before enrollment milestones
Escalate any item carrying regulatory or documentation exposure — approval lapses, ICF version mismatches, missed reporting timelines — to Clinical Operations and Administration immediately
Maintain documentation that supports, but does not substitute for, PI regulatory accountability under 21 CFR 312.60

Required Qualifications

2+ years of clinical research regulatory coordination experience at a site, SMO, CRO, or sponsor
Working knowledge of ICH GCP (E6) and 21 CFR Parts 11, 50, 54, 56, and 312
Direct experience preparing and managing IRB/IEC submissions (initial, continuing review, amendments, safety reporting)
Experience maintaining regulatory binders/eISF systems and DOA logs
High attention to detail and strong organizational skills; able to manage submission deadlines across multiple concurrent studies without missing a window
Clear, professional written communication for IRB and sponsor correspondence

Preferred Qualifications

Experience supporting multi-site or multi-PI operations
Experience with EISF, CTMS, or equivalent regulatory document management systems
Familiarity with pediatric vaccine trials or specialty areas such as podiatry, dermatology, or diabetic foot
Experience training or mentoring site staff on regulatory documentation requirements

Pay: From $18.00 per hour

Benefits:

Paid time off

Experience:

Regulatory in Clinical Research: 2 years (Required)

License/Certification:

GCP (Preferred)

Ability to Commute:

Houston, TX 77042 (Required)

Work Location: In person

Quick Apply

Refine Your Search

section coordinator jobs

Regulatory Coordinator — Clinical Research

Special Education Curriculum Coordinator

Bim Coordinator

CHESS District Wide Coordinator

Livestock Coordinator

Part-Time Curriculum & Instruction Systems Coordinator

REMOTE MDS Coordinator

Issue Resolution Specialist / Account Coordinator Hybrid

Program Coordinator

Project Coordinator - Affordable Housing

IRS / AC Hybrid

Study Coordinator I

Coordinator - Medical Staff Services

International Documentation Coordinator

PERMIT COORDINATOR

Editorial Coordinator

Executive Travel Coordinator

PERMIT COORDINATOR

Dispatch & Logistics Coordinator

Residency Program Coordinator

I want to receive the latest job alert for section coordinator

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