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The Regulatory Support Specialist, under the direction 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 guidelines for GCP, federal, state, and local regulations
- Assist with the preparation for internal and external inspections, audits, and monitor visits
- Assist in ensuring that all site documents, including SOPs and study regulatory files, are maintained in audit-ready condition
- Maintain communication with internal/external parties and the research team regarding regulatory document matters
- Work with an assigned mentor regularly for training and resource questions
Requirements:
- 3+ years of experience in Clinical Trials and GCP for all research designs
- Bachelor's Degree in a related field
- Drug-related trial experience
- Proficiency with Microsoft Office and Adobe Acrobat
Soft 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 the 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
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Science
Industries
- Hospitals and Health Care
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Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
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