Velocity Clinical Research Hiring: Specialist I, Regulatory @Hyderabad
About Velocity Clinical Research:
Velocity Clinical Research is dedicated to providing excellence in patient care, high-quality data, and innovative medical treatments. We ensure the success of clinical trials by generating high-quality data quickly while maintaining exemplary patient care. We invest in our employees’ career advancement and reward high performance. Join us, whether you’re new to clinical research or an industry veteran.
Position Details:
- Job Title: Regulatory Specialist I
- Organization: Velocity Clinical Research
- Location: Hyderabad
- Qualification: Bachelor’s, Associate’s, High School Graduate, or technical degree
- Experience: 1 – 3 years
- Salary: Not disclosed
Role Overview:
The Regulatory Specialist I is responsible for preparing and maintaining complete and accurate regulatory documents in support of clinical research studies.
Key Responsibilities:
| Responsibility | Description |
|---|---|
| Document Preparation | Prepare study-specific protocols, informed consent forms, HIPAA authorizations, and related documents for IRB review. |
| Regulatory Submissions | Support initial regulatory submission documents for IRB and sponsors, focusing on expedited study start-up. |
| Regulatory Compliance | Ensure timely regulatory submissions to avoid study start-up delays. |
| Amendments and Approvals | Prepare and submit amendments, yearly requests for continuing approval, audits, deviations, and adverse event reports. |
| Financial Disclosures | Assist staff in completing Financial Disclosure Forms for each study. |
| New Hire Support | Support new hires in completing and submitting required research documentation and training. |
| Training Tracking | Track training status for existing staff, assisting with updates as needed. |
| Documentation Maintenance | Maintain study binders with all IRB-related documents and correspondence for audit readiness. |
| Audit Preparation | Assist in preparing for monitoring visits, sponsor audits, and regulatory audits by conducting quality checks. |
| Closeout Documentation | Support the preparation and submission of closeout documents to sponsors and IRBs. |
| Adverse Event Reporting | Submit or support SAE and AE submissions to the IRB in a timely manner. |
| File Management | Ensure accurate and timely file completion to support audit and inspection readiness. |
| Safety and Compliance | Adhere to safety and compliance regulations. |
| Other Duties | Perform other duties as assigned. |
Education/Experience:
- Bachelor’s degree: 1 year of relevant experience in the life science industry
- Associate’s degree: 2 years of relevant experience in the life science industry
- High School Graduate/Technical degree: Minimum of 3 years of relevant experience in the life science industry
Required Skills:
- Knowledge of medical terminology
- Proficiency with computers, Microsoft Office, fax, copier, and multi-line telephone
- Strong verbal, written, and organizational skills
- Excellent interpersonal and communication skills
- Ability to work as a team player
- Proficiency in reading, writing, and speaking English
- Ability to multitask and follow written guidelines
- Ability to work independently, plan, and prioritize with some guidance
- Flexibility and adaptability according to clinic prioritization needs
- Detail-oriented and responsible for individual actions
- Professionalism under judgment, critique, and praise
- Understanding of ICH, GCP, and FDA regulatory requirements
Physical Abilities:
- Ability to sit or stand for long periods
- Ability to travel locally and nationally
- Effective communication in person and by telephone
- Limited walking and lifting up to 30 pounds
How to Apply:
Apply now to join our mission in bringing innovative medical treatments to patients through successful clinical trials!