Regulatory Specialist (Clinical Research)

Job Description

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 communication of regulatory process changes.

Quality, Audits & Inspection Readiness

• Conduct internal quality checks to ensure regulatory documentation is accurate, complete, and consistent.
• Identify documentation deficiencies, trends, and opportunities for process improvement.
• Assist with corrective and preventive actions (CAPAs) related to regulatory findings.
• Support sponsor audits, internal audits, quality assurance reviews, monitoring visits, and regulatory inspections.
• Track and resolve regulatory action items.
• Maintain ongoing inspection readiness of regulatory files.
• Assist with compilation of regulatory metrics and reports for leadership review.

Collaboration

• Collaborate with Study Coordinators, Study Start-Up personnel, CRAs, Investigators, sponsors, CROs, and other internal departments.
• Communicate regulatory requirements, timelines, and outstanding action items to relevant stakeholders.
• Support study activation through timely completion of assigned regulatory activities.
• Foster professional and effective working relationships with internal and external partners.

Required Qualifications

• Associate's degree required.
• 1–3 years of experience in clinical research - regulatory affairs.
• Working knowledge of ICH-GCP guidelines and applicable clinical research regulations.
• Understanding of IRB processes and regulatory submission requirements.
• Knowledge of essential clinical trial documentation and TMF requirements.
• Strong organizational skills with exceptional attention to detail.
• Ability to manage multiple priorities and deadlines simultaneously.
• Excellent written and verbal communication skills.
• Strong problem-solving and critical-thinking skills.
• Ability to work independently while collaborating effectively within a team environment.
• Proficiency with Microsoft Office applications, including Word, Excel, Outlook, and Teams.

Preferred Qualifications

• Bachelor's degree in Life Sciences, Healthcare Administration, Clinical Research, or a related field.
• Experience supporting clinical research studies within a research site, SMO, healthcare, or CRO environment.
• Experience with CTMS, eRegulatory systems, sponsor portals, or eTMF platforms.
• CCRP, CCRC, or similar clinical research certification.
• Experience supporting multiple studies across various therapeutic areas.
• Experience with sponsor audits, regulatory inspections, or quality assurance activities.
• Previous experience within an SMO environment.
• Quality control experience related to clinical documentation.

What Success Looks Like

In this role, success means:

• Regulatory submissions are accurate, complete, and submitted on time.
• Essential documents and TMFs remain current, organized, and inspection-ready.
• Regulatory deadlines and approval periods are proactively tracked and managed.
• Documentation deficiencies and outstanding items are identified and resolved promptly.
• Study teams receive timely and effective regulatory support.
• Regulatory processes are consistently performed in accordance with ICH-GCP, sponsor requirements, IRB requirements, and company SOPs.

Work Environment & Physical Requirements

This is an onsite, office-based position within a clinical research setting. The role requires prolonged periods of sitting and computer use, frequent use of standard office equipment, and the ability to move throughout office and clinical areas as needed. Occasional lifting and carrying of up to 25 pounds may be required.

Travel

Minimal local travel between research sites and company locations may be required. Occasional attendance at sponsor meetings, training sessions, or professional development activities may also be required.

Schedule

This is a full-time, exempt position with standard business hours generally Monday through Friday, 8:00 AM–5:00 PM. Additional hours may occasionally be required to meet study deadlines, support audits, or address business needs.

Equal Employment Opportunity

LINQ Research is an Equal Opportunity Employer and provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, or any other protected status under applicable law.

This job posting describes the general nature and level of work performed in this position and is not intended to be an exhaustive list of all duties, responsibilities, or qualifications. Management reserves the right to modify, assign, or remove duties as business needs dictate.