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:
Experience:
- Regulatory in Clinical Research: 2 years (Required)
License/Certification:
Ability to Commute:
- Houston, TX 77042 (Required)
Work Location: In person
