What are the responsibilities and job description for the Clinical Research Regulatory Coordinator position at Renovatio Clinical?
Company Description
Renovatio Clinical is dedicated to delivering innovative treatment options to patients through clinical research. Their mission is to ensure rapid enrollment for clinical trials and execute them efficiently. Renovatio Clinical aims to become a leading network of community-based clinical research centers while upholding values of respect, safety, teamwork, quality, efficiency, and transparency.
Role Description
This is a full-time on-site role in The Woodlands, TX for a Clinical Research Regulatory Coordinator at Renovatio Clinical. The Clinical Research Regulatory Coordinator is responsible for managing regulatory documentation and ensuring compliance with applicable local, state, and federal regulations throughout the clinical trial process. This position supports the smooth functioning of clinical research by overseeing protocol submissions, ensuring that ethics and regulatory approvals are obtained, and maintaining essential study documentation.
Qualifications
- Education: A Bachelor’s degree in a scientific, healthcare, or related field (e.g., biology, pharmacology, nursing) is typically required. Advanced certifications, such as Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), or regulatory affairs certification (e.g., Regulatory Affairs Certification (RAC)) from recognized bodies like the Regulatory Affairs Professionals Society (RAPS) are highly desirable.
- Experience: Typically requires 2-3 years of experience in clinical research, with a focus on regulatory affairs or regulatory compliance. Previous experience in clinical trials, regulatory submissions, or ethics committee interactions is preferred.
- Skills:
- In-depth knowledge of regulatory guidelines, including Good Clinical Practice (GCP), FDA regulations, and international regulatory standards.
- Experience with the preparation and submission of regulatory documents to ethics committees, regulatory agencies, and sponsors.
- Excellent attention to detail and organizational skills.
- Strong written and verbal communication skills.
- Proficiency with clinical research management software and tools, as well as document management systems.
- Ability to prioritize tasks and manage multiple regulatory submissions and deadlines.
