Associate Site Manager (Clinical Research Associate) - Job Opportunity at Johnson & Johnson

Toronto, Canada
Full-time
Entry-level
Posted: June 27, 2025
Hybrid
CAD 65,000 - 85,000 annually, based on the entry-level to mid-level positioning of this role, Toronto's competitive life sciences market, and Johnson & Johnson's reputation for competitive compensation packages in clinical operations roles

Benefits

Opportunity to work with a global healthcare leader driving breakthrough medical innovations
Field-based role providing autonomy and direct site interaction experience
Professional development through exposure to Phase 1-4 clinical trials across multiple therapeutic areas
Home office establishment support providing flexible work arrangements
Access to cutting-edge clinical trial management systems and technologies
Career advancement opportunities within Johnson & Johnson's extensive global clinical operations network

Key Responsibilities

Serve as the primary strategic liaison between Johnson & Johnson and clinical trial sites, directly impacting study success and patient outcomes
Drive patient recruitment strategies that accelerate clinical trial timelines and contribute to bringing life-saving treatments to market faster
Ensure regulatory compliance and quality standards through comprehensive site monitoring, protecting patient safety and maintaining study integrity
Deliver specialized training programs to site personnel, building capabilities that enhance clinical research standards across the healthcare ecosystem
Resolve complex site-specific challenges through collaborative problem-solving, ensuring study milestones are met and regulatory timelines are maintained
Maintain critical clinical trial documentation systems that support regulatory submissions and drug approval processes
Collaborate with cross-functional study operations teams to address protocol issues and optimize study execution efficiency

Requirements

Education

Bachelor of Science, R.N., or equivalent degree in Biological Sciences preferred

Experience

Minimum of 1 year experience in onsite and offsite (remote) monitoring; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility

Required Skills

Pharmaceutical industry clinical research trial experience preferred Analytical/risk-based monitoring experience is highly preferred Knowledge of several therapeutic areas is an asset (preferably including oncology) In-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements Ability to operate and use various systems and databases (e.g., CTMS, EDC, TMF, various dashboards/metrics, IWRS, safety reporting) Strong communication and influencing skills to effectively manage study sites both remotely and face-to-face Strong team member and self-starter with the ability to work independently Ability to establish a home office Fluent in the English language
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Industry Trends

The clinical research industry is experiencing unprecedented growth driven by post-pandemic healthcare innovation acceleration, with pharmaceutical companies increasing clinical trial investments by 15-20% annually to address unmet medical needs and capitalize on breakthrough therapies in oncology, immunology, and rare diseases. Digital transformation in clinical trials is revolutionizing the field through hybrid monitoring approaches, remote data collection, and AI-powered analytics, creating demand for CRAs who can navigate both traditional on-site monitoring and emerging virtual trial technologies. Regulatory authorities are emphasizing risk-based monitoring and quality by design principles, requiring clinical research professionals to develop sophisticated analytical skills and adapt to more strategic, data-driven approaches to site oversight and compliance management. The therapeutic focus is shifting toward personalized medicine and complex specialty areas like cell and gene therapy, creating opportunities for CRAs to specialize in high-growth therapeutic areas that command premium compensation and career advancement potential.

Role Significance

Typically manages 8-12 clinical trial sites simultaneously as part of a larger study team including senior CRAs, clinical data managers, biostatisticians, and medical monitors, with direct reporting relationships to clinical study managers and regional clinical operations directors.
This role represents an entry to mid-level position within Johnson & Johnson's clinical operations hierarchy, offering significant responsibility for site management and patient recruitment while providing a pathway to senior CRA and clinical management positions within the organization's global structure.

Key Projects

Multi-phase oncology trials investigating breakthrough immunotherapies and targeted cancer treatments Complex medical device studies requiring specialized regulatory knowledge and technical expertise Global registration studies supporting new drug applications and regulatory submissions to Health Canada and international authorities Risk-based monitoring initiatives implementing advanced analytics and remote monitoring technologies

Success Factors

Developing deep expertise in Good Clinical Practice regulations and ICH guidelines while staying current with evolving regulatory requirements and industry best practices in clinical trial management. Building strong relationships with principal investigators, site coordinators, and research staff to facilitate smooth study execution and maintain high-quality data collection standards. Mastering advanced clinical trial management systems and emerging digital technologies to optimize monitoring efficiency and support data-driven decision making in study management. Cultivating analytical and problem-solving skills to identify and resolve site-specific issues quickly while maintaining compliance with regulatory requirements and study protocols. Demonstrating flexibility and adaptability to manage multiple therapeutic areas and study phases while travelling extensively to maintain direct site relationships and oversight responsibilities.

Market Demand

High demand driven by accelerated drug development timelines, expanding clinical trial volumes, and the critical shortage of experienced clinical research professionals across the pharmaceutical industry, particularly in major biotech hubs like Toronto

Important Skills

Critical Skills

Good Clinical Practice expertise is absolutely essential as it forms the foundation for all clinical trial activities and regulatory compliance, with ongoing updates requiring continuous professional development to maintain current knowledge of evolving standards and requirements. Clinical trial management system proficiency is crucial for success in modern clinical operations, as these platforms serve as the central hub for study tracking, data management, and regulatory documentation, with advanced users commanding higher compensation and faster career progression. Communication and relationship management skills are vital for success as CRAs must influence site behavior, resolve conflicts, and maintain productive partnerships with diverse stakeholders including physicians, nurses, regulatory personnel, and internal teams across different cultural and professional backgrounds.

Beneficial Skills

Therapeutic area specialization, particularly in high-growth areas like oncology and immunology, provides significant career advantages through increased market demand, higher compensation potential, and access to cutting-edge clinical development programs. Project management certification and advanced analytical skills are increasingly valuable as the industry moves toward more strategic, data-driven approaches to clinical operations, creating opportunities for leadership roles and specialized positions in clinical analytics and process improvement.

Unique Aspects

Exposure to Johnson & Johnson's industry-leading oncology pipeline including breakthrough CAR-T therapies and precision medicine initiatives that represent the future of cancer treatment
Opportunity to work with cutting-edge clinical trial technologies and risk-based monitoring approaches that are setting new industry standards for study execution efficiency
Access to Johnson & Johnson's comprehensive global clinical operations network, providing unparalleled opportunities for international assignments and cross-cultural collaboration
Involvement in high-impact studies that directly contribute to regulatory submissions and drug approvals, offering meaningful work that translates to improved patient outcomes

Career Growth

Progression to Senior CRA typically occurs within 2-3 years with strong performance, while advancement to management roles generally requires 4-6 years of diverse clinical operations experience and demonstrated leadership capabilities

Potential Next Roles

Senior Clinical Research Associate with expanded therapeutic area responsibilities and mentoring duties for junior staff members Clinical Study Manager overseeing complete study operations including budget management, vendor oversight, and cross-functional team leadership Regional Clinical Operations Manager responsible for strategic planning and resource allocation across multiple studies and therapeutic areas Clinical Development Director leading drug development programs from early-phase through registration and commercialization

Company Overview

Johnson & Johnson

Johnson & Johnson represents the world's largest and most diversified healthcare company, with a pharmaceutical division that ranks among the top three globally in terms of revenue and pipeline strength, maintaining a robust portfolio of breakthrough therapies across oncology, immunology, neuroscience, and infectious diseases.

As an industry leader with over $50 billion in annual pharmaceutical revenue, Johnson & Johnson maintains the strongest financial position in the sector, enabling sustained investment in research and development while offering exceptional job security and career advancement opportunities for clinical operations professionals.
Johnson & Johnson's Canadian operations center in Toronto serves as a critical hub for North American clinical development activities, with significant local autonomy for study execution and strong connections to Canada's world-class academic medical centers and research institutions.
The organization emphasizes scientific excellence, patient-centricity, and collaborative teamwork while maintaining high performance standards and providing extensive professional development opportunities through internal training programs, external education support, and global mobility options.
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