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. Diffu Sphere™ is a proprietary, polymer‑based micro‑spheres 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 hyper‑localised 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 FDA‑approved 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. Eupraxia’s EP‑104GI is in a Phase 1b/2a trial (RESOLVE) for eosinophilic oesophagitis, and its EP‑104

IAR has completed a Phase 2b trial (SPRINGBOARD) for knee osteoarthritis pain. The company is building a pipeline of early‑ and late‑stage long‑acting formulations across multiple indications.

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, 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.

• Serve as lead monitor overseeing contract CRO 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 elevate 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 study initiation visits, investigator meetings, and provide 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.

• Bachelor’s degree in Life Sciences, Nursing, or related field required.
• Advanced degree (Master’s, Pharm
  
  D, MD) preferred.
• Minimum 5–7 years of clinical monitoring experience in the pharmaceutical or biotechnology industry.
• Proven track record managing high‑volume site…