Associate Site Manager – Clinical Research Associate
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Job Description
Associate Site Manager (Clinical Research Associate) managing clinical trials in Western Canada for Innovative Medicine at Johnson & Johnson. Involves patient recruitment, monitoring, and collaboration with study sites.
Responsibilities:
- 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 J&J 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 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 (TMF) as required.
Requirements:
- 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, 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 English language.
- 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.
Benefits:
- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development
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