Site Manager (Clinical Research Associate)

at  Johnson Johnson

Janssen Inc, a company of Johnson & Johnson is hiring a Site Manager (Clinical Research Associate). This position is a field-based role covering primarily British Columbia and Alberta; occasional travel outside of these provinces as needed . Ideally, the Site Manager should be located in the greater area of Vancouver, Calgary or Edmonton.

QUALIFICATIONS

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

• You are the primary point of contact for the study site; liaison with 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