Vanguard Clinical, Inc.

QA Engineer

• Provides independent quality oversight of internal and external clinical trial activities, records, and processes to ensure compliance with FDA regulations, ICH-GCP, internal SOPs, and other applicable regulatory requirements.
• Supports quality objectives across the organization and contributes to achieving departmental and company goals.
• Maintains current knowledge of applicable GxP requirements and regulatory developments and communicates relevant impacts to QA leadership and stakeholders.
• Supports the implementation, maintenance, and ongoing oversight of the Quality Management System (QMS).
• Develops, reviews, and maintains SOPs and quality documentation to ensure compliance with applicable regulatory requirements (ICH-GCP, FDA CFR, etc.).
• Provides client-facing Quality Assurance support, including development of quality documentation (e.g., SOPs, plans) and regulatory compliance guidance.
• Establishes and maintains appropriate quality standards, parameters, and controls across clinical programs and quality processes.
• Ensures ongoing compliance with applicable federal, state, local, and organizational regulations, guidelines, and policies.
• Implements and supports Clinical Quality Assurance plans aligned with GCP standards, internal policies, and procedures.
• Leads and supports inspection and audit readiness activities, including preparation, coordination, and participation in regulatory agency inspections.
• Plans, conducts, and/or supports qualification, routine, and for-cause audits, and participates in the evaluation, qualification, and ongoing oversight of clinical vendors in accordance with company SOPs.
• Oversees the management, tracking, and effectiveness of audit observations and CAPAs, including root cause analysis, trending, and escalation of systemic quality issues.
• Evaluates quality trends and metrics to identify risks, support continuous improvement, and informs QA reporting to management.
• Provides QA guidance to cross-functional teams through participation in study team meetings and interpretation of current regulatory requirements and best practices.
• Conducts or supports QA review of clinical and regulatory documents, including protocols, Investigator Brochures, Clinical Study Reports, and integrated summaries, as applicable.
• Supports the development and delivery of training materials and provides GCP and SOP-related training to internal stakeholders.
• Collaborates with clinical teams to assess and investigate temperature excursions, deviations, and product complaints reported from clinical sites.
• Participates in QA budget planning and resource forecasting activities.
• Develops, monitors, and reports GCP quality metrics to support consistent quality performance across the organization.
• Performs other duties and special projects as required.

Quality Assurance Manager

Research Analyst

• Reporting to the Director, Clinical Monitoring, primarily responsible for the management of clinical sites and monitoring of clinical data at assigned sites
• The Senior Clinical Research Associate (Sr. CRA) will independently execute monitoring responsibilities for clinical trials in Phases 1, 2, and 3, in accordance with ICH/GCP guidelines and Standard Operating Procedures (SOPs)
• Prepares for and conducts site qualification, site initiation, interim, and closeout monitoring visits
• Main point of contact between assigned sites and Sponsor
• Conducts all monitoring with a strong focus on data integrity and patient safety, adhering to GCP protocol and sponsor requirements
• Delivers high quality and timely reports following each monitoring visit
• Completes and submits monitoring-related expense reports in accordance with the company and/or Client’s travel & expense guidelines
• Works with the Clinical Operations Manager to identify, escalate, and resolve issues at assigned clinical sites
• Maintains Trial Master File (TMF)/Electronic Trial Master File (eTMF) for assigned sites
• Manages query resolution process with clinical sites and data management groups
• Travel of up to 75% may be required, including globally
• Quarterly travel to San Diego headquarters required, if not residing locally.

Senior Clinical Research Associate – Pool

• Reporting to the Director - Clinical Monitoring, primarily responsible for the management of clinical sites and monitoring of clinical data at assigned sites.
• The Clinical Research Associate (CRA) will execute monitoring responsibilities for clinical trials in Phases 1, 2, and 3, in accordance with ICH/GCP guidelines and Standard Operating Procedures (SOPs).
• Prepares for and conducts site qualification, site initiation, interim, and closeout monitoring visits.
• Main point of contact between assigned sites and Sponsor.
• Conducts all monitoring with a strong focus on data integrity and patient safety, adhering to GCP protocol and sponsor requirements.
• Delivers high quality and timely reports following each monitoring visit.
• Completes and submits monitoring-related expense reports in accordance with the company and/or Client’s travel & expense guidelines.
• Works with the Clinical Operations Manager to identify, escalate, and resolve issues at assigned clinical sites.
• Maintains Trial Master File (TMF)/Electronic Trial Master File (eTMF) for assigned sites.
• Manages query resolution process with clinical sites and data management groups.
• Travel of up to 75% may be required, including globally. Quarterly travel to San Diego headquarters required, if not residing locally.
• Other work-related duties, special projects, and/or other functions, as required.