Velocity Clinical Research is hiring for the position of Specialist I, Regulatory. This full-time regulatory role focuses on preparing, submitting, and maintaining essential regulatory documents required for clinical research studies.

The Regulatory Specialist I will support IRB submissions, study start-up activities, informed consent documentation, regulatory binder maintenance, amendments, adverse event reporting, audit readiness, and study closeout activities. Candidates with relevant life science industry experience and knowledge of ICH-GCP and FDA regulatory requirements can apply.

Job Details

About Velocity Clinical Research

Velocity Clinical Research is an integrated clinical research site organization focused on conducting high-quality clinical trials while providing excellent patient care.

The organization supports the development of innovative medical treatments by helping clinical trials recruit patients, generate high-quality research data, and operate efficiently while maintaining regulatory and ethical standards.

Job Description

As a Regulatory Specialist I, you will prepare and maintain complete and accurate regulatory documentation supporting clinical research studies.

The role involves working with study coordinators, site leadership, sponsors, and Institutional Review Boards (IRBs) to ensure regulatory submissions and essential study documents are completed accurately and within required timelines.

You will also help maintain regulatory binders, track staff training, support study start-up, prepare documentation for monitoring visits and audits, and assist with study closeout and archival activities.

Key Responsibilities

• Prepare study-specific protocols, Informed Consent Forms (ICFs), HIPAA authorizations, and other required documents for IRB review.
• Support initial regulatory submissions to IRBs and study sponsors.
• Ensure regulatory submissions are completed on time to avoid delays in clinical study start-up.
• Prepare and submit protocol amendments and annual continuing-approval requests for active studies.
• Support submission of protocol deviations, adverse event reports, audit-related documentation, and other IRB-required submissions.
• Work with study staff to complete Financial Disclosure Forms.
• Assist new employees in completing required clinical research documentation and mandatory training.
• Track training status for existing clinical research staff and support required updates.
• Ensure staff listed on Delegation of Authority (DOA) logs have appropriate training documentation on file.
• Maintain paper or electronic study regulatory binders.
• Ensure IRB documents and correspondence are properly filed and maintained for audit readiness.
• Notify staff and site leadership about upcoming training expiration dates.
• Conduct quality checks of regulatory binders before monitoring visits, sponsor audits, and regulatory audits.
• Assist with preparation and submission of study closeout documents to sponsors and IRBs.
• Ensure regulatory binders are complete and audit-ready before study closure and archival.
• Support maintenance of DOA logs and other required clinical trial logs.
• Submit or support Serious Adverse Event (SAE) and Adverse Event (AE) submissions to IRBs as required.
• Maintain accurate and timely regulatory files to support audit and inspection readiness.
• Provide copies of IRB documents to sponsors when required.
• Follow applicable safety, regulatory, and compliance requirements.
• Perform other assigned regulatory and clinical research duties.

Qualification & Experience

Candidates must meet one of the following criteria:

• Bachelor’s degree with at least 1 year of relevant experience in the life science industry, OR
• Associate’s degree with at least 2 years of relevant experience in the life science industry, OR
• High School Graduate and/or Technical Degree with a minimum of 3 years of relevant experience in the life science industry.

No specific professional license or certification is required for this position.

Required Skills

Candidates should have:

• Knowledge of medical terminology
• Understanding of ICH guidelines
• Understanding of Good Clinical Practice (GCP)
• Knowledge of FDA regulatory requirements
• Good regulatory documentation skills
• Strong written and verbal communication skills
• Good organizational and interpersonal skills
• Ability to work effectively within a team
• Ability to read, write, and communicate in English
• Ability to multitask and manage priorities
• Ability to follow written procedures and guidelines
• Ability to work independently with appropriate guidance
• Strong attention to detail
• Ability to adapt to changing clinical site priorities
• Working knowledge of computers and Microsoft Office
• Professional and accountable approach to assigned responsibilities

Benefits

Velocity Clinical Research mentions the following employee benefits:

• Medical insurance
• Dental insurance
• Vision insurance
• Paid time off
• Company holidays
• 401(k) retirement plan with company match
• Annual incentive program
• Career advancement opportunities for high-performing employees

How to Apply

Application Link