Job Description

Title: Regulatory Support Specialist

Start Date: ASAP

Location: Pleasanton, CA, 5 days/week in person

Contract: 3 month Contract to Hire

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
• Proficiency with Microsoft Office and Adobe Acrobat

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 priorites
• 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

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