Note: The job is a remote job and is open to candidates in USA. Integrated Resources, Inc. is seeking a Project Manager, Clinical Affairs – Clinical Quality to oversee clinical quality and compliance activities across U.S. and global clinical studies. The role supports audits, regulatory compliance, CAPA management, risk assessment, SOP development, training, and continuous improvement of clinical quality programs.
Responsibilities
- Audit & Monitoring: Conduct routine internal/external audits and ongoing clinical file or documentation reviews to identify compliance discrepancies to ensure sponsor audit/inspection readiness
- Regulatory Compliance: provide internal oversight of clinical studies to ensure compliance to Good Clinical Practice (GCP) guidelines, FDA regulations, ISO14155 standards, and other applicable global requirements
- CAPA Management: Assist project teams with develop, implement, and track Corrective and Preventive Action (CAPA) plans to resolve audit findings and prevent future non-compliance
- Risk Management: Identify potential clinical quality risks, escalate compliance issues to leadership, and facilitate root cause analyses (RCAs)
- Policy & Training: Support the development of Standard Operating Procedures (SOPs), best practice guidelines, clinical quality processes and tools and deliver training to ensure clinical staff are educated on quality frameworks
- Partner with internal stakeholders to develop internal processes, KPIs and drive identified initiatives
- Support the development and execution of a proactive, risk-based clinical quality and compliance program that Products participant safety, supports data integrity, and promotes continuous improvement across all clinical studies
Skills
- • Bachelor's degree in a scientific/bioengineering field (B.S.) with a minimum of 5 years of experience in clinical research
- • Strong organizational and project management skills, with strong experience of collaborating with cross-functional teams
- • Prior experience working in Clinical Quality Compliance
- • Strong knowledge of 21 CFR part 812, Good Clinical Practice ICH/GCP, ISO14155 and other regulations/guidelines. Fundamental knowledge of clinical research and monitoring requirements
- • Strong communication, presentation and interpersonal skills with high attention to detail and organization
- • Ability to learn quickly, tailor to shifting requirements
- • Results-driven attitude and strong problem-solving skills, consistently show dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary
- • Must be able to travel 25-40% or based on business requirements
- • Previous experience supporting internal and external audit on clinical studies is preferred
Benefits
- Remote work in California
Company Overview
Company H1B Sponsorship