Johnson & Johnson Careers
Site Manager (Clinical Research Associate) - Ontario
Requisition ID: 7124171215
Janssen Pharmaceutical, a company of Johnson & Johnson is hiring a Site Manager. This position is a field based role. This position will cover the Province of Ontario with occasional travel outside of the province. The preferred location is the Toronto area.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.ca for more information.
The Site Manager will be part of the Global Clinical Operations (GCO) Canada group and will be responsible for site management through the assessment/selection, initiation, maintenance and closure phases of a clinical trial (Phase 1 – 4).
- Primary contact for the site; liaison with study teams.
- Proactively drive subject recruitment.
- Monitor according to GCP standards and GCO SOPs (to include source document verification, Trial Centre File review and accurate drug accountability).
- Fully document trial related activities for each visit in monitoring visit reports. Promptly communicate relevant status information to appropriate team members.
- Responsible for timely resolution of site-specific issues and partnering with site to meet study milestones.
- Work with in-house team to resolve protocol-specific issues.
- Site staff training, during site initiation and ongoing, to ensure compliance with all required regulations, SOPs, trial–specific tools and systems, and specialized procedures.
- Maintain complete, accurate and timely data and essential documents in the systems utilized for trial management [e.g. clinical trial management system (CTMS); electronic Trial Master File (TMF)].
- A minimum of a Bachelor’s degree or completion of a Nursing Program (RN) is required. A Bachelor’s degree in a Health or Science discipline is preferred.
- A minimum of 1 year of clinical trial monitoring or relevant clinical research experience is required.
- Prior experience with any of the following therapeutic areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines.
- Bilingualism (English & French) is an asset.
- Ability to learn, operate and proactively use various systems and databases (e.g. CTMS, eDC, TMF).
- Knowledge of analytical risk-based monitoring is an asset.
- Environment to establish a home office.
- Willingness to travel up to 50% (up to 2-3 days per week) with overnight stays (up to 1-2 nights on average), is required.
- Must have strong oral and written communication skills.
- Knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements is preferred.
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 have the opportunity to achieve their potential.
Janssen Inc. (7710)
Clinical Trial Administration