Associate Site Manager (Clinical Research Associate) - 2 Openings

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function

R&D Operations

Job Sub Function

Clinical Trial Support

Job Category

Professional

All Job Posting Locations:

Toronto, Ontario, Canada

Job Description

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.

Learn more at https://www.jnj.com/innovative-medicine

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.