Summary:

The Regulatory Support Specialist, under director of the Clinical Trials Compliance Director, will provide regulatory support to the Northern California PI and research sites conducting multiple FDA-regulated or other clinical trials.

Responsibilities:

• Compliance Monitoring and Reporting with IRB Standard Operating Procedures and document applications
• Adhere to Guideline for GCP, federal, sate, and local regulations
• Assist with the preparation for internal and external inspections, audits and monitor visits
• Assist in assuring that all site documents, including SOPs and study regulatory files, are maintained in audit-ready condition
• Maintain communication with internal/external parties and research team regarding regulatory document matters
• Work with an assigned mentor on a regular basis for training and resource questions
• Attend Sponsor site initiation meetings

Requirements:

• 3+ years of experience in Clinical Trials and GCP for all research designs
• Bachelor's Degree in related field
• Drug-related trial experience

Soft Skills:

• Demonstrate excellent organizational skills
• Must be able to work successfully with a wide variety of project staff and research participants
• Must be dependable and able to follow detailed protocols precisely
• Have ability to work with shifting priorities
• Exhibit a professional manner with a high degree of courtesy, tact, and sensitivity
• Work well independently as well as part of a larger multi-disciplinary research team
• Proficiency with Microsoft Office and Adobe Acrobat