Associate Site Manager
2 weeks ago
**Job Function**:
R&D Operations
**Job Sub**Function**:
Clinical Trial Support
**Job Category**:
Professional
**All Job Posting Locations**:
Toronto, Ontario, Canada
**About Innovative Medicine**:
**Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.**:
**Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.**:
**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.**:
- **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.**:
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