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 submit your CV and cover letter at link below.

While only short-listed candidates will be notified, we thank each applicant for their submission.

Job Description: 

The Pharmaceutical Paralegal provides comprehensive legal and administrative assistance to the Legal, Compliance, and Privacy activities within Eupraxia pharmaceuticals and its related companies. This role focuses upon on matters related to pharmaceutical regulation, intellectual property, contracts, data protection initiatives, and corporate governance activities. The Paralegal role helps ensure the company operates in compliance with applicable healthcare, data privacy, and pharmaceutical laws and regulations across global jurisdictions. It supports the company in managing the company’s legal obligations and risk.

Reports to: Senior Director of Legal Affairs, Privacy & Data Protection Officer

Key Responsibilities:

Contract Management

• Draft, review, and maintain templates for contracts, NDAs, clinical trial agreements, vendor and supply agreements, and research collaborations.
• Manage the contract lifecycle using contract management systems and ensure timely renewals or terminations.

 

Legal Research and Compliance Monitoring

• Conduct legal research on pharmaceutical laws, data privacy, advertising, and anti-bribery regulations.
• Support the implementation of compliance programs and employee training initiatives.

 

Litigation and Risk Management Support

• Help prepare discovery materials, summarize documents, and coordinate with litigation counsel as needed.

 

Privacy & Data Protection Support

• Support the Privacy Office with compliance under GDPR, HIPAA, CCPA, and other applicable privacy laws.
• Assist in managing data processing agreements (DPAs) and vendor due diligence related to data protection.
• Help maintain records of processing activities (RoPA) and privacy documentation.
• Support privacy impact assessments (PIAs) and incident response processes, including documentation of breaches or data subject requests.
• Coordinate privacy training and awareness initiatives across departments.

 

Qualifications:

• Bachelor’s degree in paralegal studies, Legal Studies, Life Sciences, or a related field.
• Paralegal certificate from an accredited program (preferred).
• 3–5 years of experience as a paralegal, preferably within the pharmaceutical, biotechnology, or healthcare industry.
• Knowledge of FDA regulations, Good Clinical Practice (GCP), and data protection laws (HIPAA, GDPR).
• Experience with contract management systems and document management tools (e.g., DocuSign).
• Excellent written, organizational, and analytical skills.
• Strong attention to detail and ability to handle confidential information.
• Excellent verbal, written and interpersonal communication skills.
• Is able and willing to travel internationally, especially between Canada, US and Europe

 

Additional attributes:

• 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

 

Salary Range:  CAD$ 100,000 – 115,000 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 submit your CV and cover letter at link below.

While only short-listed candidates will be notified, we thank each applicant for their submission.