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We are searching for the best talent for an Associate Site Manager (Clinical Research Associate). This position is a field-based role covering primarily the Greater Toronto Area, Ontario; occasional travel outside of this province as needed. Ideally, the Associate Site Manager should be located in the Greater Toronto Area.

Purpose:

As an Associate Site Manager (Clinical Research Associate), you will be part of the Global Clinical Operations (GCO) Canada team 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 will be responsible for:

• 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.

Qualifications / 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 the 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.