Regulatory Support Specialist

Get AI-powered advice on this job and more exclusive features. 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 Referrals increase your chances of interviewing at Medasource by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified about new Support Specialist jobs in Pleasanton, CA . #J-18808-Ljbffr Medasource