Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

Summary





The Regualtory Specialist I prepares and maintains complete and accurate regulatory documents in support of clinical research studies.

Responsibilities

Role & Responsibilities:

Prepare each study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB.
Supports initial regulatory submission documents for IRB and sponsors to ensure site meets regulatory readiness metrics with a focus on expedited study start up
Ensures regulatory submissions are done in a timely manner as to not delay study start up
Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, deviations, adverse event reports, and any other IRB-required submissions.
Work with staff members to complete Financial Disclosure Forms for each study.
Assist recent hires in completing and submitting all required research documentation and trainings by their deadlines.
Assist coordinators and site leadership

📌 Specialist I, Regulatory (Hyderabad)
🏢 Velocity Clinical Research
📍 Hyderabad