Eupraxia Pharmaceuticals Inc. · 6 hours ago
Lead Clinical Research Associate US
Seattle, WA
Full-time
Hybrid
Senior Level
$80K/yr - $120K/yr
5+ years expEupraxia Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on developing innovative drug delivery systems. They are seeking an experienced Lead Clinical Research Associate to manage high-volume site portfolios and ensure compliance with clinical trial regulations across multiple regions.
Biotechnology
Responsibilities
Serve as lead monitor overseeing contract CRO’s monitoring teams with a high-volume portfolio of active sites
Conduct routine and for-cause monitoring and site visits, ensuring compliance with ICH-GCP, FDA regulations, and study protocols
Perform comprehensive source data verification, regulatory document review, and investigational product accountability
Identify and escalate site performance issues, implementing corrective and preventive action plans (CAPA)
Ensure timely resolution of data queries, protocol deviations, and site-level audit findings
Manage site initiation, activation, and close-out activities with precision and efficiency
Attend SIV’s, Investigator Meetings, and perform onsite training and support as needed
Conduct training sessions on monitoring best practices, GCP compliance, and study-specific procedures
Review and approve monitoring reports prepared by team members
Serve as an escalation point for complex site issues and challenging investigator relationships
Participate in cross-functional team meetings representing the site monitoring perspective
Ensure all site activities maintain the highest quality standards and regulatory compliance
Identify potential risks to data integrity, patient safety, and study timelines
Implement risk-based monitoring strategies to optimize site oversight
Prepare for and support regulatory inspections and audits at clinical sites
Maintain comprehensive and audit-ready trial master file documentation
Collaborate with study teams to achieve enrollment targets and maintain study timelines
Build and maintain strong relationships with principal investigators, site coordinators, and institutional staff
Facilitate effective communication between sites and internal stakeholders
Contribute to continuous process improvement initiatives within clinical operations
Participate in site selection, feasibility assessments, and investigator meetings
Qualification
Required
Bachelor's degree in Life Sciences, Nursing, or related field required
Minimum 5-7 years of clinical monitoring experience in the pharmaceutical or biotechnology industry
Proven track record managing high-volume site portfolios
Extensive experience with Phase II and Phase III global clinical trials
Demonstrated expertise in monitoring across Canada, Australia, Europe and the USA regions
Expert knowledge of ICH-GCP guidelines, FDA regulations (21 CFR Parts 50, 56, 312), and EU Clinical Trial Directive
Proficiency with electronic data capture (EDC) systems (Medidata Rave, Oracle Inform, or similar)
Strong understanding of clinical trial processes from start-up through close-out
Experience with CDISC standards, source data verification, and data quality management
Competency in CTMS platforms and eTMF systems
Exceptional organizational skills with the ability to manage multiple priorities simultaneously
Outstanding attention to detail and commitment to data quality
Strong problem-solving abilities and sound clinical judgment
Excellent written and verbal communication skills in English
Proven ability to work independently with minimal supervision
Cultural sensitivity and adaptability for international travel and site interactions
Resilience in high-pressure, fast-paced environments
Preferred
Advanced degree (Master's, PharmD, MD)
Experience in Gastrointestinal disorders and/or a nursing background strongly preferred
Previous lead or senior CRA role with oversight responsibilities
Additional European languages a plus
Benefits
Bonus will be available based on performance and remaining in post for the agreed contract duration
Competitive benefits package
Strong emphasis on work/life balance
Supportive company culture
Company
Eupraxia Pharmaceuticals Inc.
Eupraxia Pharmaceuticals is a public, clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase