Overview
QA / Regulatory specialist Jobs in San Francisco Bay Area at SF Research Institute
Title: QA / Regulatory specialist
Company: SF Research Institute
Location: San Francisco Bay Area
Support the day-to-day operations of assigned activities within SFRI to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
Prepare, review, and submit regulatory documents to ensure compliance with local and international regulations, including IRB submissions, clinical trial applications, and ethical review processes.
Coordinate regulatory activities during the pre-study phase, including the preparation and submission of regulatory documents, obtaining necessary approvals, and ensuring compliance with sponsor and regulatory agency requirements.
Monitor ongoing trials to ensure adherence to regulatory standards and guidelines, assist with audits, and ensure that all documentation, including informed consent and clinical trial protocols, meets regulatory requirements.
Oversee the close-out phase of clinical trials, ensuring that all regulatory reports are filed accurately and on time, including final study reports, regulatory notifications, and necessary documentation for trial closure.
This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives
Generate and provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools
Proactively identify and escalate issues that arise related to support SFRI deliverables
Support implementation of standards for global SFRI team
Oversight of site level SFRI activities from receipt of a potential site list to site activation under the direction of Dr. John Ademola, including NDA and contract negotiations, ICF negotiations, IRB/EC submissions, IMP release and other site activation requirements
Building relationships with internal counterparts and site staff to support successful site activation strategies
Projecting site activation timelines and appropriately escalating when things get off track Aiding in the preparation of content for Regulatory submissions
Knowledge of and experience with, clinical research startup process, including research administration compliance considerations.
Experience with project management processes and systems and leading large projects with multiple stakeholders.
Ability to create and implement standard process documentation and tools (checklists, workflow diagrams, project management software).
Represent self and company in a professional manner and in line with core company values.
Practice excellent internal and external customer service, communication, and team work
