Velocity Clinical Research Hiring for Specialist I, Regulatory
Are you ready to advance your career in the world of clinical research? Velocity Clinical Research is seeking a motivated and detail-oriented Specialist I, Regulatory to join our dynamic team in Hyderabad. If you are passionate about ensuring that life-changing treatments are brought to patients through efficient and effective clinical trials, this is the perfect opportunity for you.
At Velocity, we’re more than just a research site organization; we are a group of dedicated professionals striving to make a difference in healthcare by delivering exceptional results in clinical trials. With a strong focus on patient care, data quality, and innovation, we provide a supportive work environment that values your contributions and fosters growth.
Here’s a quick look at the job details:
| Role | Specialist I, Regulatory |
|---|---|
| Experience | 1 to 2 years |
| Location | Hyderabad |
| Qualifications | Bachelor’s degree or equivalent |
| Required Skills | FDA knowledge, Microsoft Office proficiency, multitasking |
Why Choose Velocity Clinical Research?
Velocity Clinical Research is a globally recognized organization that collaborates on cutting-edge clinical trials. By joining our team, you will contribute directly to the success of these trials, helping to bring new treatments to market. At Velocity, your professional development is a priority. We offer opportunities for career growth and continuous learning in a collaborative and innovative environment. Our benefits package is comprehensive, ensuring that you are well taken care of. It includes:
- Medical, dental, and vision insurance
- Paid time off and company holidays
- 401(k) retirement plan
- Annual incentives
Your Responsibilities as a Specialist I, Regulatory
In this role, you will play a critical part in ensuring that clinical trials meet regulatory requirements. You’ll be involved in preparing essential documents, maintaining timelines, and supporting the study process from start to finish. Here are some of the key responsibilities you’ll handle:
- Prepare and maintain study protocols, informed consent forms, and other related regulatory documents.
You will ensure that all the necessary paperwork is in place and that it meets the regulatory standards needed for clinical trials. - Support initial regulatory submissions to meet study readiness metrics.
Your work will help expedite the study startup process, ensuring that the research is conducted in a timely and effective manner. - Ensure timely submission of regulatory documents.
You’ll manage the submission of essential paperwork to avoid delays and ensure that clinical trials progress smoothly. - Prepare amendments, audit reports, and other IRB-required documents.
Keeping track of updates and maintaining compliance with regulatory standards will be a vital part of your role. - Assist with Financial Disclosure Forms and track staff training documentation.
Your attention to detail will be crucial in handling sensitive information and maintaining accurate records. - Maintain study binders and assist in audit readiness.
You’ll ensure that all documentation is organized and accessible for audits, supporting site leadership during sponsor and regulatory inspections.
What You Need to Succeed
To excel in this role, we are looking for someone with a strong foundation in regulatory affairs and a keen understanding of clinical trials. Here’s what we’re looking for:
- A Bachelor’s degree with 1 year of relevant experience in the life sciences industry, OR
- An Associate’s degree with 2 years of relevant experience, OR
- A High School Graduate or technical degree with 3 years of relevant experience.
You should also possess the following skills:
- Strong knowledge of medical terminology and FDA regulatory requirements.
Understanding the language of clinical trials and regulatory standards is essential to your success in this role. - Proficiency with Microsoft Office and computers.
You’ll need to be tech-savvy to manage documents, submissions, and communication efficiently. - Excellent verbal and written communication skills.
Clear and professional communication is a must, as you’ll be interacting with various teams and regulatory bodies. - Organizational skills and attention to detail.
Managing multiple tasks, deadlines, and documents requires excellent time management and the ability to prioritize effectively. - Ability to work independently and adapt to clinic needs.
Flexibility and initiative will help you thrive in this fast-paced and ever-changing environment.
Why This Role is Perfect for You
If you are passionate about the regulatory side of clinical research and want to be part of a team that is dedicated to innovation and improving patient outcomes, this is the role for you. As a Specialist I, Regulatory, you’ll have the opportunity to support groundbreaking research while building your career in a field that’s growing rapidly.
Velocity Clinical Research offers not only a job but a platform for personal and professional growth. You’ll be working alongside experts in the field, contributing to life-changing treatments, and experiencing the satisfaction of being part of an organization that values its people.
Take the next step in your career by joining Velocity Clinical Research. Apply today and be a part of something bigger!
