Lead Clinical Research Associate

Eupraxia Pharmaceuticals Inc. • Vancouver • 1d ago

Lead Clinical Research Associate About Us: Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support an extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians want to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, also to be applicable in oncology, infectious disease and other critical disease areas. Eupraxia's EP-104GI is currently in a Phase 1b/2a trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com. We are looking for someone who would like to work for a fast-paced, growing company that fosters a creative spirit and integrated teamwork and who is eligible to work in Canada or the United States. 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 high-volume site portfolios across Canada, Australia, Europe and the USA. The ideal candidate will demonstrate exceptional site management skills, strong leadership capabilities, and a proven track record of delivering quality monitoring outcomes and site deliverables in complex, multi-national clinical trials. Travel Requirement: Up to 50% domestic and international travel (Canada, Australia, Europe and USA) Reports to: SVP, Clinical Operations Key Responsibilities: Site Management & Monitoring 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. Leadership & Mentorship 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 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 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 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: Bachelor's degree in Life Sciences, Nursing, or related field required Advanced degree (Master's, PharmD, MD) preferred 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 Experience in Gastrointestinal disorders and/or a nursing background strongly preferred Previous lead or senior CRA role with oversight responsibilities 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 (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 high-pressure, fast-paced environments Additional attributes: High-Volume Management: Demonstrated ability to efficiently manage and oversee 40+ active sites while maintaining quality standards Travel Flexibility: Willingness and ability to travel extensively (50%), including international trips of 1-2 weeks duration Relationship Building: Exceptional interpersonal skills to establish trust and credibility with diverse site personnel Proactive Leadership: Self-starter who anticipates challenges and implements solutions independently Technical Proficiency: Advanced computer skills, including MS Office, electronic systems, and virtual monitoring tools Time Management: Ability to prioritize competing demands and meet aggressive timelines Adaptability: Flexibility to adjust to changing study requirements, timelines, and travel schedules Strong analytical and problem-solving abilities Detail-oriented with strong organizational skills and the ability to manage multiple priorities Self-starter who thrives in a fast-paced, dynamic environment Ability to work both independently and collaboratively across teams Professional presentation with excellent written and verbal communication skills Flexible within a constantly changing environment 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 15 pounds (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$ 80,000 – 120,000 annually Within the posted range, individual pay is determined by job-related skills, relevant experience, education and/or training. Please note that the range details above reflect the 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. This is an opportunity to work in a small, entrepreneurial, and highly motivating environment, with a strong emphasis on work/life balance and a supportive company culture. How to Apply: Please apply via the link provided in the advertisement. While only short-listed candidates will be notified, we thank each applicant for their submission.