What are the responsibilities and job description for the Regulatory Specialist position at Prolato Clinical Research Center?
About Prolato Clinical Research Center:
Prolato Clinical Research Center is at the forefront of conducting vital clinical studies in areas such as Nephrology, Cardiology, Autoimmune Diseases, and more. Our dedicated team of over 20 professionals is passionate about advancing medical knowledge and improving patient care. At Prolato, we offer innovative healthcare solutions through a broad range of clinical trials, bringing hope to individuals facing serious health challenges.
Position Summary:
We are seeking a detail-oriented and experienced Regulatory Affairs Specialist to join our team at our Kirby Dr location. In this role, you will ensure compliance with regulatory standards, manage essential documentation, and serve as a liaison with regulatory authorities and study sponsors. This position provides an excellent opportunity to contribute to cutting-edge research and make a meaningful impact in the clinical research field.
Key Responsibilities:
- Regulatory Compliance:
- Ensure all clinical trials comply with FDA, ICH, GCP, and other applicable regulations.
- Stay informed about regulatory changes and assess their implications for current and future studies.
- Document Preparation and Management:
- Prepare and submit essential regulatory documents, including IRB submissions, safety reports, and protocol amendments.
- Maintain regulatory logs, including IRB logs, SAE logs, and protocol deviation logs.
- Ensure all regulatory documentation is accurate, complete, and filed in a timely manner.
- Sponsor and Regulatory Communication:
- Act as the primary liaison with regulatory authorities and study sponsors for study approvals and compliance matters.
- Address inquiries and provide required documentation promptly.
- Support Clinical Operations:
- Collaborate with study teams to ensure compliance throughout all phases of clinical trials.
- Assist in preparing for site audits and inspections by ensuring regulatory readiness.
- Training and Oversight:
- Provide guidance and training to research staff on regulatory requirements and best practices.
Qualifications:
- Education:
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field (advanced degrees preferred).
- Experience:
- Minimum of 3 years in regulatory affairs, preferably within the clinical research or pharmaceutical industry.
- Certifications:
- Good Clinical Practice (GCP) certification (required).
- Regulatory Affairs Certification (RAC) or similar credentials (preferred).
- Skills:
- Comprehensive knowledge of FDA, ICH, and GCP guidelines.
- Proficiency in regulatory submission tools, clinical trial management systems (CTMS), and document management systems.
- Excellent attention to detail, communication, and organizational skills.
Why Join Prolato?
At Prolato, you will join a passionate and collaborative team committed to improving patient care through high-quality research. We foster a supportive work environment where innovation and growth are encouraged. By joining us, you’ll have the opportunity to make a meaningful impact in advancing medical science and developing life-changing treatments.
Benefits:
- Flexible schedule (with some in-office requirements)
- Health insurance
- Paid time off
Schedule:
- 8-hour shift
- Monday to Friday
- Somewhat flexible scheduling
Job Type: Full-time
Pay: From $75,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
Schedule:
- 8 hour shift
Ability to Commute:
- Houston, TX 77054 (Required)
Ability to Relocate:
- Houston, TX 77054: Relocate before starting work (Required)
Work Location: In person
Salary : $75,000