Regulatory Support Specialist

Medasource; Pleasanton (CA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading company in healthcare is seeking a Regulatory Support Specialist to provide regulatory support for clinical trials. The role involves compliance monitoring, preparation for inspections, and maintaining communication with research teams. Candidates should have a Bachelor's degree and at least 3 years of relevant experience, along with proficiency in Microsoft Office and Adobe Acrobat.

Qualifications

• 3+ years of experience in Clinical Trials and GCP.
• Drug-related trial experience required.
• Ability to work with shifting priorities.

Responsibilities

• Monitor compliance with IRB SOPs and document applications.
• Prepare for internal and external inspections and audits.
• Maintain audit-ready condition of site documents.

Skills

Compliance Monitoring

GCP

Communication

Dependability

Professionalism

Education

Bachelor's Degree in a related field

Tools

Microsoft Office

Adobe Acrobat

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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