|Position Type||Full Time|
|Application Deadline||May 30, 2021|
|Experience Required||5+ years|
MaxSys is currently looking for a Senior Clinical Research Associate for our client in the west end
THIS IS A PERMANENT ROLE AND OFF-SITE!!!
Secondary school diploma is required
Bachelor in Science from a Canadian University
6 years+ experience
Remote monitoring (required)
Strong leadership skills, ability to mentor, train others
Medical Device experience (asset/not required)
Experience creating documents
Duties that may include, but not limited to:
Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions.
Ensures validity of study by identifying/resolving discrepancies and obtaining missing data and may track core lab activities and more complex components of the trial.
Contributes to developing and writing clinical protocols, case report forms, and other study aids for investigational products by addressing issues by interacting with appropriate personnel.
Maintains expertise in regulations for applicable geographies and types of studies (IDE, non¬ significant risk, feasibility, exempt, etc.). Serves as a resource related to clinical trial regulations.
May mentor and train new employees.
Serves as a trainer for contract research organizations (CROs) needed for additional monitoring support.
Ensures timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Responsible for implementing the strategic initiatives established by the business and the department.
Responsible for tactical components of creating and driving customer-centric relationships cross-functionally to support product developments throughout the product(s) life cycle.
Subject matter expert (SME) in the technical application of product portfolio.
Execution of all aspects of testing including design, developing test materials, protocols, evaluation of test data, and all around support of analysis. Responsible for the execution of all aspects of clinical studies including but not limited to: site selection, pre-study visits, essential document review, site close-outs.
Other miscellaneous duties as may be required.
If you meet all the above requirements, please send your resume today to Katherine Spallin at:
*Please note, only qualified candidates will be contacted and the position could be filled prior to closing date. Thank you.*