Entry-level regulatory specialist role at Velocity Clinical Research

Specialist I Regulatory – Clinical Research

Bachelor/MSc Regulatory Specialist, 1–3 yrs experience, clinical trial regulatory submissions and IRB management.

Entry-level regulatory specialist role supporting clinical trial start-up, IRB submissions and audit-ready Trial Master File maintenance. This position suits detail-focused life-science graduates who understand GCP, can manage regulatory timelines and enjoy working across clinical teams to keep studies compliant and on schedule.

Company Overview

Velocity Clinical Research operates integrated, patient-focused research sites with a mission to accelerate clinical trials while delivering high-quality patient care. Their sites combine investigator expertise, streamlined operations and rigorous data standards to reduce study start-up time and improve enrolment. Velocity supports career growth with training, clear performance metrics and benefits that include medical, dental and vision plans, paid time off, 401(k) match and annual incentives.

Job Role & Responsibilities

As a Specialist I, Regulatory you will be responsible for preparing, submitting and maintaining regulatory documents that are essential for clinical study start-up and conduct. The role is execution-heavy: you’ll handle IRB submissions, amendments, continuing reviews, safety reports and maintain study binders (paper or electronic) so that each site is inspection-ready at all times.

Key responsibilities

• Draft and assemble study-specific documents: protocol, informed consent forms (ICFs), HIPAA authorizations and other trial-specific paperwork for IRB and sponsor review.
• Lead initial regulatory submissions and follow through until approvals are obtained, ensuring no delays to study activation.
• Manage amendments, continuing review requests, deviations reports, adverse event (AE) and serious adverse event (SAE) submissions to IRBs and sponsors in a timely manner.
• Maintain accurate regulatory binders (TMF/ISF) and electronic regulatory files; perform routine quality checks to ensure audit readiness.
• Track training status and regulatory documentation for clinical staff; assist new hires with credentialing and required research training.
• Support site leadership and coordinators during monitoring visits, sponsor audits and regulatory inspections; prepare required documentation and perform pre-visit QC checks.
• Maintain delegation of authority (DOA) logs, financial disclosure forms and other site-level regulatory logs.
• Support study close-out activities: compile and submit closeout packages to sponsors and ensure proper archival of regulatory records.
• Monitor regulatory timelines and notify site staff of upcoming expirations and required submissions.
• Participate in local and national travel when required for audits, training or sponsor meetings.

Eligibility / Qualifications

Required education and experience

• Bachelor’s degree with 1 year of relevant life-science or clinical research experience; OR
• Associate’s degree with 2 years of relevant experience; OR
• High school graduate/technical certificate with a minimum of 3 years relevant experience in the life science industry.

Required skills and competencies

• Solid understanding of ICH-GCP and FDA regulatory expectations for clinical research.
• Familiarity with medical terminology and clinical trial documentation.
• Strong written and verbal communication skills; professional correspondence with IRBs and sponsors.
• Highly organized with excellent attention to detail and the ability to manage multiple regulatory timelines.
• Competent with Microsoft Office (Word, Excel, Outlook) and common eTMF/eRegulatory systems.
• Ability to work independently with some guidance and to adapt to shifting priorities in a fast-paced site environment.
• Team player who can coordinate with clinical, operations and sponsor contacts.
• Willingness and ability to travel locally or nationally when requested.

Preferred attributes

• Prior site regulatory or TMF/eTMF experience.
• Certified in clinical research (e.g., ACRP/SoCRA) or regulatory affairs exposure.

Physical and workplace requirements

• Ability to sit or stand for extended periods.
• Limited walking and occasional lifting (up to 30 lbs).
• Clear verbal communication for in-person and phone interactions.

Location & Benefits

This is a regular full-time, on-site role (telecommute: No). Velocity offers a competitive benefits package including medical, dental and vision insurance, paid time off, company holidays, 401(k) with company match and an annual incentive program. The position may require local and national travel.

Application Process

Apply online via Velocity’s careers portal: https://careers-velocityclinical.icims.com/jobs/3239/specialist-i%2c-regulatory/job

Application checklist (recommended)

• Updated CV with relevant regulatory experience highlighted.
• Copies of relevant degrees or certifications.
• Brief cover note (2–3 lines) summarizing your TMF/eTMF and IRB experience.

Why this role matters (E‑A‑T focus)

Regulatory specialists are the backbone of compliant clinical research. Accurate submissions and timely regulatory maintenance protect participant safety, ensure data integrity and keep sponsors on track to meet trial milestones. Velocity’s Specialist I role gives you direct influence on study readiness and offers exposure to monitoring, audits and cross-functional trial operations — all critical for building a robust regulatory career.

High‑value keywords included naturally

Clinical research jobs, regulatory affairs, IRB submissions, trial master file, eTMF, GCP compliance, clinical trial start-up, regulatory specialist, FDA submissions, site regulatory coordinator.

Relevant courses (comma-separated)

BSc (Life Sciences), BPharm, MSc (Clinical Research), M.Pharm, Postgraduate Diploma in Clinical Research, Diploma in Regulatory Affairs, BSc Nursing, BHMS, BAMS, Clinical Research Certification (ACRP/SoCRA), Good Clinical Practice (GCP) training

FAQs

Q: What minimum education is required?
A: The role accepts a range of education levels: Bachelor’s with 1 year experience; Associate’s with 2 years; or technical/high-school diploma with 3 years relevant experience.

Q: Is remote work allowed?
A: No — this is an on‑site role. Travel to other sites for audits or sponsor meetings may be required.

Q: What systems should I already know?
A: Proficiency with Microsoft Office is required. Experience with eTMF/eRegulatory systems or TMF management is preferred.

Q: Are there clear career progression steps?
A: Yes. Velocity supports career growth — top performers can move to Regulatory Specialist II, Regulatory Lead, or Site/Study Start-up management roles.

Q: Will I handle safety reporting?
A: Yes. The role supports SAE/AE submissions to the IRB and may assist with sponsor reporting processes.

Quick tips to strengthen your application

• Highlight any hands-on TMF/eTMF or IRB submission experience with specific examples (e.g., number of studies supported, average turnaround times achieved).
• Include GCP training certificates and any clinical research certifications.
• Demonstrate teamwork: show examples where you supported coordinators during monitoring visits or audits.

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+----------------------+-----------------------------------------------+
| Company              | Velocity Clinical Research                     |
+----------------------+-----------------------------------------------+
| Vacancies            | Specialist I, Regulatory                       |
+----------------------+-----------------------------------------------+
| Required Education   | Bachelor’s (1 yr exp) / Associate’s (2 yrs) /  |
|                      | Technical/HS (3 yrs exp)                       |
+----------------------+-----------------------------------------------+
| Experience           | 1–3 years relevant clinical research/regulatory|
+----------------------+-----------------------------------------------+

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