Clinical Research Analyst

University Health Network • Toronto, ON

6d • CA$34 - CA$42 • Onsite

About The Position

The Correlative Studies Program (CSP) provides comprehensive clinical research biospecimen management services that support translational cancer research and clinical trials conducted through the Cancer Clinical Research Unit (CCRU) at Princess Margaret Cancer Centre. The program facilitates the collection, processing, storage, shipment, and management of high-quality biospecimens to advance the discovery and validation of novel cancer diagnostics and therapies. The Clinical Research Analyst (CRA) is responsible for coordinating biospecimen management activities across multiple clinical trials, ensuring compliance with institutional policies, study protocols, Good Clinical Practice (GCP), International Council for Harmonization (ICH-GCP), Health Canada, FDA, Tri-Council guidelines, and applicable transportation and customs regulations (IATA). The CRA oversees international biospecimen logistics, regulatory documentation, equipment and quality records, study tracking, and operational workflows to ensure the timely, compliant, and efficient movement of biospecimens while maintaining specimen integrity. A significant component of this role is administrative coordination and documentation management. The incumbent is responsible for maintaining complete and accurate study records, shipping documentation, regulatory files, equipment maintenance records, quality documentation, inventories, databases, and operational trackers.

Requirements

• Bachelor's degree, or recognized equivalent, in a health, life science, or related discipline required
• One to two years of experience in clinical research, laboratory operations, biospecimen management, or a related field required
• Knowledge of biospecimen collection, processing, storage, shipping, cold chain management, and specimen preservation techniques.
• Working knowledge of Good Clinical Practice (GCP), ICH-GCP, Health Canada, FDA, Tri-Council guidelines, and applicable regulations governing clinical research and human biological materials.
• Knowledge of international shipping requirements, customs regulations, and import/export processes for human biological materials
• Proficiency with Microsoft Office applications and data management systems

Nice To Haves

• TDG and/or IATA certification is considered an asset.
• Experience preparing international shipping documentation, customs paperwork, and coordinating compliant biospecimen shipments is preferred.
• experience with EPIC and sponsor electronic requisition systems is considered an asset.
• Demonstrated ability to manage multiple priorities in a fast-paced environment while maintaining a commitment to quality, customer service, regulatory compliance, and continuous improvement.

Responsibilities

• Coordinate domestic and international shipment of human biospecimens in compliance with study protocols, IATA Dangerous Goods Regulations, TDG, GCP, and applicable regulatory requirements.
• Prepare, review, and maintain shipping and customs documentation, including commercial invoices, import/export permits, chain of custody records, and regulatory documentation required for international transport.
• Monitor biospecimen collection schedules, coordinate courier services, track shipments from pickup to delivery, and proactively resolve transportation and customs issues to ensure timely specimen delivery.
• Coordinate incoming biospecimen shipments from participating clinical trial sites and facilitate sponsor-specific electronic requisition systems and related study documentation.
• Maintain complete, accurate, and audit-ready study documentation, including biospecimen inventories, study trackers, databases, shipping records, quality metrics, and regulatory files.
• Maintain laboratory equipment records by coordinating routine maintenance and calibration, filing service documentation, and managing temperature monitoring records for regulatory compliance.
• Prepare operational reports, summaries, and presentations related to biospecimen volumes, turnaround times, quality indicators, and program performance.
• Monitor inventory levels of laboratory supplies and biospecimen collection kits to ensure operational readiness and continuity of service.
• Issue, investigate, and resolve study- and shipment-related queries while liaising with sponsors, clinical sites, couriers, customs brokers, and receiving laboratories to support efficient program operations.
• Participate in departmental meetings, maintain current knowledge of applicable regulations and industry best practices, and contribute to quality improvement initiatives and regulatory compliance activities.

Benefits

• Competitive offer packages
• Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP)
• Close access to Transit and UHN shuttle service
• A flexible work environment
• Opportunities for development and promotions within a large organization
• Additional perks (multiple corporate discounts including: travel, restaurants, parking, phone plans, auto insurance discounts, on-site gyms, etc.)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level