Clinical Research Regulatory Specialist
2 weeks ago
About the Job and the Company:
Join Alcanza, a dynamic multi-site clinical research company with a widespread presence in different states across the US. We focus on various therapeutic areas such as vaccine, neurology, dermatology, psychiatry, and general medicine, conducting Phase I-IV studies, and aiming for continuous growth.
Job Description:
The Regulatory Specialist plays a crucial role in ensuring regulatory compliance, maintaining quality control, and providing organizational training on GCP and SOP adherence. Responsibilities include overseeing regulatory documents, communicating with the IRB, conducting site-focused reviews, and contributing to quality improvement activities.
Key Responsibilities:
- Maintain regulatory documents in an organized manner for efficient monitoring and auditing of research studies.
- Ensure compliance with SOPs, facilitate communication with IRB and Sponsors, and assist in the development of clinical trial support documents.
- Track approvals and renewals, report on the status of clinical trials, and ensure adherence to federal regulations and ICH/GCP guidelines.
- Generate and review regulatory data reports, uphold quality standards, and provide support in training programs.
- This role may involve remote work with occasional travel to the Decatur, GA site.
Skills, Knowledge and Expertise:
- A Bachelor's degree and at least 2 years of clinical research experience, or equivalent education/experience.
- 1+ years of regulatory experience preferred, with knowledge of GCP/ICH guidelines.
- Proficiency in Microsoft applications, email, EHR systems, and typing (40+ wpm).
- Strong organizational, communication, interpersonal, and problem-solving skills.
- Ability to work independently, handle sensitive information professionally, and adapt to changing priorities.
- High integrity, self-motivation, and a strong work ethic are essential.
Benefits:
- Eligible full-time employees receive a comprehensive benefits package, including medical, dental, vision insurance, life and disability coverage, 401k plan, and more.
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