Velocity Clinical Research Hiring Regulatory Specialist I to support clinical trials with regulatory submissions, document maintenance, and audit readiness.
Introduction
Velocity Clinical Research, a leading integrated clinical research site organization, has announced an opening for the position of Specialist I, Regulatory. This full-time, onsite role is ideal for professionals who want to contribute to high-quality clinical research while ensuring accuracy, compliance, and regulatory readiness across all study activities. As one of the most respected research site networks, Velocity plays a crucial role in accelerating clinical trials and bringing innovative medical treatments to patients faster, without compromising quality and patient safety. Velocity Clinical Research Hiring Regulatory Specialist
As a Regulatory Specialist I, you will play an essential role in preparing, submitting, and maintaining accurate regulatory documents that support clinical research studies. From preparing IRB submissions to maintaining regulatory binders, the Specialist ensures every study remains audit-ready and compliant with ICH, FDA, and GCP guidelines.
This detailed job post covers responsibilities, qualifications, skills, benefits, and the complete application process. Velocity Clinical Research Hiring Regulatory Specialist
Key Highlights
| Key Information | Details |
|---|---|
| Company | Velocity Clinical Research |
| Role | Specialist I, Regulatory |
| Category | Regulatory |
| Job Type | Regular Full-Time |
| Telecommute | No |
| Location | Onsite (United States – Exact site as per Velocity location) |
| Experience | 1–3 years depending on education level |
| Industry | Clinical Research / Clinical Trials |
| ID | 2025-3239 |
About Velocity Clinical Research
Velocity Clinical Research is an industry-leading organization operating fully integrated clinical research sites dedicated to conducting high-quality, patient-centered clinical trials. The company works closely with pharmaceutical and biotechnology sponsors to accelerate the development of innovative medical treatments. Velocity’s mission focuses on generating high-quality data while ensuring that patients receive exceptional care throughout their participation in clinical trials. Velocity Clinical Research Hiring Regulatory Specialist
Velocity is known for its expertise, robust site infrastructure, and commitment to operational excellence. Employees at Velocity are regarded as essential contributors to the organization’s success. The company invests significantly in employee development, career progression, and performance-based rewards. Velocity Clinical Research Hiring Regulatory Specialist
Employee benefits include:
- Medical, dental, and vision insurance
- Paid time off and company holidays
- 401(k) plan with company match
- Annual incentive program
- Supportive and growth-oriented workplace culture
Whether you are new to clinical research or an experienced professional, Velocity provides an ideal environment for learning, career building, and contributing to impactful medical advancements. Velocity Clinical Research Hiring Regulatory Specialist
Role Summary: Specialist I, Regulatory
The Regulatory Specialist I is responsible for preparing, organizing, and maintaining accurate regulatory documents that support clinical research studies. This position ensures that all regulatory submissions, IRB documents, and essential study files meet compliance standards and are audit-ready at all times. Velocity Clinical Research Hiring Regulatory Specialist
The role requires strong attention to detail, understanding of clinical research regulations, excellent communication skills, and the ability to multitask in a fast-paced research environment. Velocity Clinical Research Hiring Regulatory Specialist
Detailed Responsibilities
1. Prepare Study-Specific Regulatory Documents
You will prepare essential study documents such as:
- Study protocols
- Informed consent forms
- HIPAA authorization documents
- Study-related IRB documents
These materials must reflect complete accuracy and alignment with study requirements before being submitted for IRB review.
2. Manage Initial Regulatory Submissions
You will support regulatory submissions to IRBs and sponsors to ensure the site meets all regulatory readiness requirements. Your work is directly tied to the speed and success of site startup activities.
3. Handle Amendments and Ongoing Submissions
The role includes preparing and submitting amendments, adverse event reports, deviations, audits, and continuing review applications for open protocols. Ensuring documents are submitted on time prevents delays in trial operations. Velocity Clinical Research Hiring Regulatory Specialist
4. Maintain Training and Delegation Logs
You will assist with:
- Tracking staff training status
- Submitting new staff documentation
- Ensuring credentials match delegation of authority logs
- Notifying staff of training expirations
This ensures that all team members remain qualified and compliant.
5. Regulatory Binder Maintenance
You will maintain both paper and electronic regulatory binders that must remain audit-ready at all times. All IRB correspondence, approvals, updates, and essential documents must be stored accurately and systematically.
6. Support Audits and Monitoring Visits
Before audits, monitoring visits, and sponsor inspections, you will:
- Conduct quality checks
- Ensure binder completeness
- Support coordinators and site leadership
Your role helps ensure the site remains in regulatory compliance throughout the study. Velocity Clinical Research Hiring Regulatory Specialist
7. Support Closeout Activities
You will assist in preparing and submitting regulatory closeout documents, ensuring proper archival of trial data and closure of all logs and regulatory files as required.
8. Safety Submissions
You will submit or support timely reporting of:
- Serious Adverse Events (SAEs)
- Adverse Events (AEs)
Accurate reporting ensures participant safety and compliance with IRB, FDA, and ICH regulations. Velocity Clinical Research Hiring Regulatory Specialist Velocity Clinical Research Hiring Regulatory Specialist
9. Administrative and Support Functions
Additional duties may include providing IRB documents to sponsors, adhering to safety regulations, and supporting the research team with other regulatory tasks as assigned.
Qualifications and Eligibility Criteria
Educational Requirements
Candidates may qualify through any of the following education–experience combinations:
- Bachelor’s degree + 1 year of experience in life sciences
- Associate degree + 2 years of relevant life sciences experience
- High school diploma/technical degree + 3 years of experience in life sciences
Required Skills
To succeed in this role, candidates must demonstrate:
- Strong understanding of medical terminology
- Proficiency in Microsoft Office and basic office equipment
- Strong written and verbal communication skills
- Ability to multitask effectively
- High level of attention to detail
- Ability to work independently with minimal supervision
- Ability to follow written guidelines accurately
- Knowledge of ICH, GCP, and FDA regulations
- Strong organizational and time-management skills
- Ability to collaborate within a team environment
- Professional behavior and accountability
Physical Abilities Required
- Ability to sit or stand for extended periods
- Ability to travel locally or nationally as required
- Ability to communicate effectively in person and by phone
- Limited walking and lifting up to 30 pounds
Work Environment
The role is performed onsite within a clinical research setting. Regulatory specialists interact frequently with coordinators, site leadership, auditors, sponsors, and IRBs. The environment requires maintaining high-quality documentation, staying organized, and managing multiple regulatory deadlines simultaneously. Velocity Clinical Research Hiring Regulatory Specialist
Velocity Clinical Research emphasizes professionalism, patient safety, regulatory accuracy, and team collaboration. The workplace culture is structured to support learning, career development, and continuous improvement. Velocity Clinical Research Hiring Regulatory Specialist
How to Apply
Interested and eligible candidates can apply directly through Velocity Clinical Research’s official careers portal by searching for the job ID 2025-3239 – Specialist I, Regulatory. Applicants should ensure their resume highlights relevant experience in regulatory affairs, clinical research, or documentation management. Once the application is submitted, suitable candidates will be contacted for further evaluation and interviews. Velocity Clinical Research Hiring Regulatory Specialist
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