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About the Role

The Correlative Studies Program (CSP) provides comprehensive clinical research biospecimen management services that support translational cancer research and clinical trials. The Clinical Research Analyst (CRA) is responsible for coordinating biospecimen management activities across multiple clinical trials, ensuring compliance with institutional policies, study protocols, and various regulatory guidelines. This role involves administrative coordination and documentation management for the timely, compliant, and efficient movement of biospecimens while maintaining specimen integrity.

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.

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.
Experience preparing international shipping documentation, customs paperwork, and coordinating compliant biospecimen shipments is preferred.
Strong organizational, analytical, problem-solving, and time management skills with exceptional attention to detail and accuracy.
Excellent verbal and written communication skills, with the ability to collaborate effectively with clinical teams, sponsors, couriers, customs agencies, and external laboratories.
Proficiency with Microsoft Office applications and data management systems.
Demonstrated ability to manage multiple priorities in a fast-paced environment while maintaining a commitment to quality, customer service, regulatory compliance, and continuous improvement.

Skills

TDG and/or IATA certification is considered an asset.
Experience with EPIC and sponsor electronic requisition systems is considered an asset.

Location

Princess Margaret Cancer Centre

Work Type

Permanent Full-time

Experience Level

One to two years of experience

Education Level

Bachelor's degree

Salary/Compensations

CAD 33.80 - CAD 42.25 - hourly

Benefits

Competitive offer packages
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
Multiple corporate discounts (travel, restaurants, parking, phone plans, auto insurance discounts, on-site gyms, etc.)

About the Company

UHN is Canada’s #1 hospital and the world’s #1 publicly funded hospital.
With 10 sites and more than 44,000 TeamUHN members, UHN consists of Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, The Michener Institute of Education and West Park Healthcare Centre.
As Canada's top research hospital, the scope of biomedical research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care.
UHN has the largest hospital-based research program in Canada, with major research in neurosciences, cardiology, transplantation, oncology, surgical innovation, infectious diseases, genomic medicine and rehabilitation medicine.
UHN is a research hospital affiliated with the University of Toronto.
UHN’s vision is to build A Healthier World and it’s only because of the talented and dedicated people who work here that we are continually bringing that vision closer to reality.

Equal Opportunity

UHN is an equal opportunity employer committed to an inclusive recruitment process and workplace.
Requests for accommodation can be made at any stage of the recruitment process. Applicants need to make their requirements known.