Job Overview
We are seeking a highly motivated and detail-oriented Clinical Research Regulatory Specialist to join our dynamic research team. In this role, you will oversee the regulatory compliance and documentation processes essential for the successful conduct of clinical trials. Your expertise will ensure that all research activities adhere to strict FDA regulations, ICH Good Clinical Practice (GCP) standards, and healthcare compliance guidelines. This position offers an exciting opportunity to contribute to groundbreaking medical research while maintaining the highest standards of ethical and regulatory integrity.
Responsibilities
- Manage and oversee regulatory documentation review, ensuring accuracy, completeness, and compliance with FDA regulations, ICH GCP guidelines, and local healthcare laws.
- Coordinate submission of regulatory documents to Institutional Review Boards (IRBs) and regulatory agencies, maintaining detailed records of approvals and correspondence.
- Supervise clinical trial documentation processes, including protocol adherence, patient consent forms, case report forms (CRFs), and adverse event reports.
- Monitor patient safety and data integrity by reviewing clinical data collection procedures and ensuring compliance with ethical guidelines such as clinical ethical standards and HIPAA regulations.
- Collaborate with clinical research teams to ensure proper training on regulatory requirements, EMR systems, and data management protocols.
- Conduct audits of trial sites for compliance with Good Clinical Practice (GCP), healthcare policies, and research project management standards.
- Support clinical laboratory activities involving blood sampling, phlebotomy procedures, vital signs monitoring, and analysis skills to ensure accurate data collection in accordance with CDISC standards.
Skills
- Supervising experience in clinical research or healthcare settings with strong leadership capabilities.
- Extensive knowledge of clinical trials management, including protocol development, patient monitoring, and research setting experience.
- Proficiency in medical terminology, clinical laboratory procedures, and blood sampling techniques such as phlebotomy.
- Expertise in documentation review, data collection practices, and adherence to clinical ethical guidelines.
- Familiarity with statistical software tools used for data analysis in research projects.
- Deep understanding of FDA regulations, HIPAA compliance requirements, and healthcare industry standards.
- Experience working with EMR systems and data management platforms aligned with CDISC standards.
- Certification in ICH GCP (Good Clinical Practice) from a recognized issuer for CA or equivalent credentials.
- Strong analysis skills combined with project management experience in healthcare or clinical research environments.
- Ability to manage multiple projects efficiently while maintaining meticulous attention to detail in all regulatory activities.
Pay: $50,678.08 - $55,000.00 per year
Benefits:
- 401(k)
- Health insurance
- Paid time off
- Professional development assistance
- Retirement plan
Work Location: In person
