Specialist I, Regulatory

1-3 years

Not Disclosed

Remote

10 March 9, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Specialist I, Regulatory
Employer: Velocity Clinical Research
Category: Regulatory
Job ID: 2025-2583
Position Type: Regular Full-Time
Telecommute: No

Overview:

Velocity Clinical Research is an integrated research site organization committed to excellence in patient care, high-quality data, and efficient clinical trials. Our goal is to bring innovative medical treatments to patients by generating reliable data quickly while maintaining exceptional patient care.

At Velocity, employees are integral to our mission. We invest in career advancement, performance rewards, and growth opportunities for high-performing individuals. Whether you're new to clinical research or an industry veteran, we welcome you to apply.

Benefits:

Medical, dental, and vision insurance
Paid time off and company holidays
401(k) retirement plan with company match
Annual incentive program

Summary:

The Regulatory Specialist I is responsible for preparing and maintaining accurate regulatory documents to support clinical research studies.

Responsibilities:

Prepare study-specific protocols, informed consent forms, HIPAA authorization, and other IRB-related documents.
Support initial regulatory submission documents for IRB and sponsors to ensure regulatory readiness and expedited study start-up.
Ensure timely regulatory submissions to avoid delays in study initiation.
Prepare and submit amendments, yearly approval requests, audits, deviations, adverse event reports, and other IRB-required documents.
Assist staff in completing Financial Disclosure Forms for each study.
Help new hires complete and submit required research documentation and training by deadlines.
Track and update training status for existing staff.
Ensure all staff on delegation of authority (DOA) logs have the necessary training.
Maintain study binders (paper or electronic) with all IRB-related documents for audit readiness.
Notify staff and Site Manager/Director of upcoming training expiration dates.
Assist site leadership in preparing for monitoring visits, sponsor audits, and regulatory inspections.
Prepare and submit closeout documents to sponsors and IRBs, ensuring completeness and proper archival of trial data.
Maintain DOA logs and other required logs as needed.
Submit or support serious adverse event (SAE) and adverse event (AE) reports to the IRB promptly.
Ensure audit and inspection readiness through accurate and timely file completion.
Provide IRB documents to sponsors as needed.
Adhere to safety and compliance regulations.
Perform other duties as assigned.

Qualifications:

Education & Experience:

Bachelor’s degree with 1 year of relevant experience in the life science industry OR
Associate’s degree with 2 years of relevant experience in the life science industry OR
High School Graduate/Technical Degree with 3 years of relevant experience in the life science industry

Required Skills:

Knowledge of medical terminology
Proficiency in Microsoft Office and office equipment (fax, copier, multi-line telephone)
Strong verbal, written, and organizational skills
Excellent interpersonal and communication abilities
Ability to work independently and as a team player
Strong multi-tasking and time management skills
Ability to follow written guidelines and prioritize tasks
Detail-oriented with high professionalism
Understanding of ICH, GCP, and FDA regulatory requirements

Physical Requirements:

Ability to sit or stand for long periods
Local and national travel may be required
Ability to communicate in person and via phone
Limited walking and lifting (up to 30 lbs.)

Disclaimer:

This job description outlines the general responsibilities of the role and may be subject to modifications as needed. Employees must perform duties within their capability as required by management.

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Specialist I, Regulatory

Job Description

Overview:

Benefits:

Summary:

Responsibilities:

Qualifications:

Education & Experience:

Required Skills:

Physical Requirements:

Disclaimer:

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