Job Description

Janssen Ortho is hiring a Clinical Research Associate, Site Manager. This position is a field-based role covering primarily Ontario; occasional travel outside of this province as needed. The preferred location is: Greater Toronto Area.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Ortho is part of the Janssen Pharmaceutical Companies.

As a Site Manager (Clinical Research Associate), you will be part of our Global Clinical Operations (GCO) Canada group within Research & Development and will be responsible for study site management through the assessment/selection, initiation, maintenance and closure phases of a clinical trial (Phase 1 - 4 trials).

• You are the primary point of contact for the clinical trials study site; liaison with clinical trials study teams.
• Your responsibilities include actively identifying and driving patient recruitment strategies at assigned sites.
• You are responsible for monitoring the study/site according to GCP standards and our Janssen GCO SOPs, both on-site and with remote contacts. This includes source document verification, Investigator Site File (ISF) review and accurate drug accountability.
• You will provide site training, during site initiation and ongoing, to ensure compliance with all required regulations, SOPs, trial-specific tools and systems, and specialized procedures.
• You will ensure resolution of site-specific issues and will partner closely with investigator and site staff to meet all our study timelines.
• You will work closely with the local study operations team to resolve protocol and site-specific issues.
• You will use and maintain the clinical trial tracking system (CTMS) and update the electronic Trial Master File (eTMF) as required.

Qualifications

• Minimum Bachelor of Science, Registered Nurse, or equivalent degree in Biological Sciences.
• Minimum of 1 year experience in onsite and offsite (remote) monitoring; however, other relevant clinical research / project management experiences and skills may be considered.
• 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, eTMF, 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
• Travel: 30-50%. Onsite monitoring visits will be conducted in combination with Offsite (remote) monitoring visits. You will be assigned sites mainly within your region/province, with occasional need for travel to neighboring provinces

At Johnson & Johnson, we\'re on a mission to change the trajectory of health for humanity. That starts by creating the world\'s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of full COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing, and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive, and accessible work environment where all employees can achieve their potential.

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