Associate Site Manager

Johnson & Johnson Innovative Medicine•Toronto, ON

1d•CA$72,000 - CA$116,150•Remote

About The Position

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) – Greater Toronto Area. This position is a field-based role covering primarily 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).

Requirements

Bachelor of Science or equivalent degree in Biological Sciences required.
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.
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.

Nice To Haves

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).

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.