Stanford University is seeking a Clinical Trials Regulatory Specialist 2 to be responsible for the oversight, administration and regulatory compliance of clinical research within the Divisions of Stroke and Neurocritical Care, and representing the university with external regulatory agencies, both domestic and international. Responsibilities will include regulatory preparation, maintenance and support for numerous Principal Investigators. In addition, position will be responsible for regulatory oversight of at least one Stanford-led multi-site research study. Projects include Industry Sponsored, federally funded, and PI-initiated trials. Additionally, this position will cross-functionally oversee regulatory education & training for coordinators, PIs and Sub-Investigators.
Duties include:
- Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual reports.
- Serve as expert liaison in compliance or scientific areas between investigators and regulatory agencies.
- Develop, deliver and manage educational and training tools.
- Oversee and maintain regulatory documentation and safety reporting procedures.
- Evaluate and analyze the impact of new regulations and ensure compliance.
- Serve as primary liaison on safety issues with internal organizations.
- Manage projects related to regulatory activities and clinical operations.
- Hire, orient, and train regulatory staff.
- Contribute to establishing SOPs for clinical research.
Qualifications include a Bachelor's degree and five years of related experience or a relevant combination, with strong knowledge of regulatory affairs, excellent communication skills, and experience in clinical research management.
The role may require occasional travel and involves working in a dynamic research environment. The salary range is approximately $120,551 to $134,914 per year. Stanford offers extensive benefits and a commitment to diversity and inclusion.
