About this opportunity
Medasource lists this Regulatory Support Specialist opportunity in pleasanton, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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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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Worksite address
pleasanton, CA, 94566, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.