Clinical Research Regulatory Specialist

Responsibilities

• •As a Clinical Research Regulatory Specialist, you will play a crucial role in ensuring compliance with all regulatory standards and guidelines for our cutting-edge pediatric research studies
• •We are seeking a detail-oriented and knowledgeable individual to join our dynamic team and make a meaningful impact on the lives of children and families
• •Ensure compliance with all regulatory standards and guidelines for clinical research studies at Children's Hospital Colorado
• •Develop and maintain a thorough understanding of healthcare industry regulations, including Good Clinical Practice (GCP) guidelines and federal and state laws
• •Act as the primary point of contact for regulatory agencies and provide timely and accurate responses to inquiries and audits
• •Collaborate with research teams to ensure that all necessary regulatory documents and protocols are in place and up to date
• •Monitor and track regulatory submissions and approvals, and maintain accurate and organized records
• •Review informed consent forms and study protocols for compliance with regulatory requirements
• •Provide guidance and support to research staff on regulatory issues and assist with resolving any compliance-related issues
• •Conduct internal audits to ensure ongoing compliance and identify areas for improvement
• •Participate in the development and implementation of training programs and educational materials related to regulatory compliance
• •Stay up to date on changes in regulations and communicate any updates or changes to the research team
• •Maintain confidentiality of sensitive information and ensure the security of all regulatory documents
• •Serve as a subject matter expert and resource for all regulatory-related inquiries
• •Monitor and report on any potential risks or non-compliance issues and work with the appropriate parties to address and resolve them
• •Maintain a positive and collaborative working relationship with all members of the research team
• •Continuously seek opportunities to improve and streamline regulatory processes and procedures
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