Regulatory Specialist Job at Velocity Clinical Research
A rare chance for aspiring professionals to step into a Regulatory Specialist Job at Velocity Clinical Research. This entry-level position offers an opportunity to contribute to clinical research while ensuring compliance with regulatory standards. Candidates interested in entry-level life science jobs are encouraged to apply.
About Velocity Clinical Research
Velocity Clinical Research is an integrated research site organisation dedicated to providing excellence in patient care and high-quality data. The organisation focuses on aligning its values and behaviours to support its mission of delivering innovative medical treatments to patients. With a commitment to making clinical trials succeed, Velocity aims to generate high-quality data from a diverse patient population while ensuring exemplary patient care at every step. This commitment makes Velocity a notable player in the field of regulatory jobs in India.
Job Details:
- Position: Specialist I, Regulatory
- Company: Velocity Clinical Research
- Category: Regulatory
- Position Type: Regular Full-Time
- Telecommute: No
- ID: 2026-3428
Job Description
The Regulatory Specialist I prepares and maintains complete and accurate regulatory documents in support of clinical research studies. This Regulatory Specialist Job is essential for ensuring compliance with regulatory requirements and facilitating the smooth operation of clinical trials.
Key Responsibilities
- Prepare each study-specific protocol, informed consent form, HIPAA authorization, and other related documents for review by the IRB.
- Support initial regulatory submission documents for IRB and sponsors to ensure site meets regulatory readiness metrics.
- Ensure timely regulatory submissions to avoid delays in study start-up.
- Prepare and submit amendments, yearly requests for continuing approval, audits, deviations, and adverse event reports.
- Assist new hires in completing and submitting all required research documentation and training by their deadlines.
- Maintain study binder with all IRB-related documents and correspondence for each study.
- Assist site leadership in preparation for monitoring visits, sponsor audits, and regulatory audits.
- Adhere to safety and compliance regulations while performing other duties as assigned.
Regulatory Specialist Job Eligibility Criteria
- 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 and/or technical degree with a minimum of 3 years relevant experience in the life science industry.
Required Skills
- Demonstrated knowledge of medical terminology.
- Ability to use technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
- Strong verbal, written, and organizational skills.
- Effective interpersonal and communication skills.
- Ability to work as a team player and independently.
- Detail-oriented with the ability to multi-task and follow written guidelines.
- Understanding of ICH, GCP, and FDA regulatory requirements.
Why Join?
Velocity Clinical Research offers a supportive environment for career advancement and rewards high performance. The organisation values its employees as integral parts of its mission and is committed to providing the necessary resources for growth, making it an excellent choice for those seeking entry-level life science jobs in a dynamic field.
Summary
The opportunity for a Regulatory Specialist Job at Velocity Clinical Research is a significant step for candidates looking to build a career in clinical research. With a focus on compliance and patient care, Velocity provides a platform for aspiring professionals to thrive. Interested candidates are encouraged to apply for this Velocity Clinical Research vacancy at the earliest to not miss out on this promising opportunity.
