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 Biologica...