Regulatory Specialist; Clinical Research

Job Description

LINQ Research, LLC
Location: Pearland, TX - Onsite
Job Type: Full-Time
Schedule: Monday-Friday, 8:00 AM-5:00 PM
Department: Regulatory
Reports To: Manager, Regulatory
FLSA Status: Exempt

About LINQ Research

LINQ Research is a growing clinical research organization committed to conducting high-quality clinical research while maintaining the highest standards of regulatory compliance, documentation, and study conduct.

We are seeking a Regulatory Specialist to join our Regulatory Affairs team. This position is responsible for supporting the regulatory management of new and ongoing clinical research studies and ensuring regulatory documentation remains accurate, complete, current, and inspection-ready.

Position Overview

The Regulatory Specialist plays an important role in the successful execution of clinical research studies by coordinating regulatory submissions and maintaining essential study documentation throughout the study lifecycle.

This position works closely with Investigators, Study Coordinators, Study Start-Up personnel, sponsors, CROs, CRAs, IRBs, and internal departments to ensure regulatory requirements and deadlines are met.

The ideal candidate is highly organized, detail-oriented, proactive, and comfortable managing multiple studies, documents, deadlines, and stakeholders simultaneously.

Key Responsibilities

Regulatory & Study Management

• Provide regulatory support for new and ongoing clinical research studies.
• Prepare, coordinate, and submit regulatory documents to sponsors, CROs, and IRBs.
• Manage regulatory activities throughout the study lifecycle, including study start-up, amendments, continuing reviews, reportable events, maintenance, and study closeout.
• Support pre-award activities, including Confidential Disclosure Agreements (CDAs) and feasibility questionnaires.
• Review and maintain investigator and site essential documents for completeness and accuracy.
• Track regulatory submissions and ensure required documentation is completed within established timelines.
• Participate in study team meetings and communicate regulatory status, pending actions, and submission updates.

TMF & Document Management

• Maintain Trial Master Files (TMFs) and ensure essential documents are complete, compliant, and filed timely.
• Conduct ongoing quality control reviews to identify missing, incomplete, expired, or incorrectly filed documentation.
• Ensure documentation is maintained in accordance with ICH-GCP guidelines, company SOPs, and sponsor-specific requirements.
• Conduct TMF reconciliation activities with sponsors and CROs, as applicable.
• Track outstanding essential documents and follow up with study personnel.
• Prepare regulatory files for monitoring visits, sponsor audits, quality reviews, and regulatory inspections.
• Maintain regulatory tracking databases, logs, and document management systems.

IRB & Regulatory Submissions

• Prepare and submit IRB applications, continuing reviews, amendments, renewals, and reportable events.
• Coordinate collection of supporting documentation required for regulatory submissions.
• Monitor IRB approval periods and maintain regulatory calendars.
• Maintain accurate records of IRB correspondence, approvals, and regulatory communications.
• Provide guidance to site staff regarding IRB processes and submission requirements.

Regulatory Compliance & Training

• Maintain Delegation of Authority Logs (DOA/DOAL) and coordinate updates with study personnel.
• Coordinate collection and maintenance of staff qualifications, licenses, training records, and certifications.
• Ensure protocol-specific training documentation is completed and appropriately maintained.
• Support onboarding and training related to regulatory processes and documentation expectations.
• Assist with implementation and…