Job Title

About Us Eupraxia is a clinicalstage biotechnology company focused on developing locally delivered, extendedrelease products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere is a proprietary, polymerbased microspheres technology designed to facilitate targeted drug delivery of both existing and novel drugs. The platform supports an extended duration of effect, delivering drugs in a hyperlocalised fashion to the tissues physicians want to treat. Precision targeting may reduce adverse events by producing stable, flat delivery rather than the peaks and troughs seen with traditional drug delivery methods. The technology has the potential to augment and transform FDAapproved drugs to improve safety, tolerability, efficacy and duration of effect. Potential therapeutic applications include pain, inflammatory gastrointestinal disease, oncology, infectious disease and other critical areas. Eupraxias EP104GI is in a Phase1b/2a trial (RESOLVE) for eosinophilic oesophagitis, and its EP104IAR has completed a Phase2b trial (SPRINGBOARD) for knee osteoarthritis pain. The company is building a pipeline of early and latestage longacting formulations across multiple indications. Job Description We are seeking an experienced and highly motivated Lead Clinical Research Associate to join our Clinical Operations team. This role requires a seasoned professional who excels in managing highvolume site portfolios across Canada, Australia, Europe, and the USA, demonstrating exceptional site management skills, strong leadership capabilities, and a proven track record of delivering quality monitoring outcomes and site deliverables in complex, multinational clinical trials. Travel is required up to 50% of the time, domestically and internationally. The position reports to the SVP of Clinical Operations. Key Responsibilities Serve as lead monitor overseeing contract CRO monitoring teams with a highvolume portfolio of active sites. Conduct routine and forcause monitoring and site visits, ensuring compliance with ICHGCP, FDA regulations, and study protocols. Perform comprehensive source data verification, regulatory document review, and investigational product accountability. Identify and elevate site performance issues, implementing corrective and preventive action plans (CAPA). Ensure timely resolution of data queries, protocol deviations, and sitelevel audit findings. Manage site initiation, activation, and closeout activities with precision and efficiency. Attend study initiation visits, investigator meetings, and provide onsite training and support as needed. Leadership & Mentorship Conduct training sessions on monitoring best practices, GCP compliance, and studyspecific 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 crossfunctional team meetings representing the site monitoring perspective. Quality & Compliance Ensure all site activities maintain the highest quality standards and regulatory compliance. Identify potential risks to data integrity, patient safety, and study timelines. Implement riskbased monitoring strategies to optimize site oversight. Prepare for and support regulatory inspections and audits at clinical sites. Maintain comprehensive and auditready trial master file documentation. Study Execution 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. Qualifications Bachelors degree in Life Sciences, Nursing, or related field required. Advanced degree (Masters, PharmD, MD) preferred. Minimum 57 years of clinical monitoring experience in the pharmaceutical or biotechnology industry. Proven track record managing highvolume site portfolios. Extensive experience with PhaseII and PhaseIII global clinical trials. Demonstrated expertise in monitoring across Canada, Australia, Europe, and the USA regions. Experience in gastrointestinal disorders and/or a nursing background strongly preferred. Previous lead or senior CRA role with oversight responsibilities. Expert knowledge of ICHGCP guidelines, FDA regulations (21CFR Parts50,56,312), and EU Clinical Trial Directive. Proficiency with electronic data capture (EDC) systems (MedidataRave, OracleInform, or similar). Strong understanding of clinical trial processes from startup through closeout. 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 problemsolving abilities and sound clinical judgment. Excellent written and verbal communication skills in English (additional European languages a plus). Proven ability to work independently with minimal supervision. Cultural sensitivity and adaptability for international travel and site interactions. Resilience in highpressure, fastpaced environments. Additional Attributes Demonstrated ability to efficiently manage and oversee 40+ active sites while maintaining quality standards. Willingness and ability to travel extensively (50%), including international trips of 12 weeks duration. Exceptional interpersonal skills to establish trust and credibility with diverse site personnel. Selfstarter who anticipates challenges and implements solutions independently. Advanced computer skills, including MS Office, electronic systems, and virtual monitoring tools. Ability to prioritize competing demands and meet aggressive timelines. Flexibility to adjust to changing study requirements, timelines, and travel schedules. Strong analytical and problemsolving abilities. Detailoriented with strong organizational skills. Ability to work both independently and collaboratively across teams. Professional presentation with excellent written and verbal communication skills. Motivated and adaptable team player with the ability to prioritize and meet deadlines. Physical Requirements & Work Environment Extensive travel (50%) by air and ground to clinical sites internationally. Ability to work flexible hours across multiple time zones. Prolonged periods of sitting during flights and site visits. Ability to lift and transport materials up to 15pounds (study supplies, documents). Professional office environment and clinical site settings. Virtual work environment when not traveling (home office setup provided). Must maintain a valid passport and the ability to travel internationally. Salary Range CAD$80,000120,000 annually. Within the posted range, individual pay is determined by jobrelated skills, relevant experience, education, and/or training. This range reflects base pay only. A bonus will be available based on performance and remaining in post for the agreed contract duration. We also offer a competitive benefits package. How To Apply Please apply via the link provided in the advertisement. While only shortlisted candidates will be notified, we thank each applicant for their submission. #J-18808-Ljbffr