Joshua Davis
Clinical Research Quality Assurance Analyst @ Houston Methodist
- Role
- Clinical Research Quality Assurance Analyst at Houston Methodist
- Location
- Houston, TX, US
- LinkedIn followers
- 500 followers
About Joshua Davis
Behavioral insights and healthcare research professional with over 10 years of experience…
Experience
Clinical Research Quality Assurance Analyst
Nov 2022 — Present · Houston, TX, US
Act as the lead QA compliance analyst, ensuring adherence to GCP standards across all clinical research phases.• Coordinate and develop educational content for the Clinical Research Education Series (CRES), the Clinical Research Orientation Program (CROP), and the Annual Clinical Research Conference.• Conduct thorough reviews and updates of the Quality Management System (QMS) to maintain regulatory standards and industry best practices.• Serve as the primary contact for regulatory authorities and study teams during inspections and sponsor audits, ensuring all QA and compliance queries are addressed effectively.• Lead the preparation and submission of assessment reports and responses to findings, enhancing the integrity of clinical research projects.• Enhanced and implemented QA Assessment process to identify and mitigate compliance risks.• Perform regular internal GCP / QA assessments, providing strategic recommendations based on findings.• Engage with key stakeholders to share updates, gather feedback, and drive QA and compliance-related process improvement initiatives.• Build and nourish strong relationships with clinical trial teams, ensuring alignment with QA compliance requirements and fostering cooperative interactions.• Identify areas for quality improvement in clinical processes and systems, designing and implementing solutions that enhance efficiency and compliance.• Lead cross-functional teams in the execution of process enhancements, tracking the effectiveness of implemented changes and CAPA recommendations. • Conduct regular training sessions for team members and stakeholders on GCP compliance, new regulations, and industry trends.• Lead and manage QA team, setting clear objectives, monitoring performance, and fostering professional development.• Prepare and present detailed reports and updates at stakeholder meetings, ensuring all parties are informed of compliance statuses and project timelines.
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.