English

Parexel•Quebec, ON

27d

About The Position

At Parexel, we are dedicated to improving the world's health through comprehensive clinical development solutions. As a Clinical Research Associate (CRA), you will play a crucial role in building and maintaining relationships with clinical sites, ensuring their success and the integrity of studies. You will be the primary point of contact for sites, addressing issues and questions, and managing site quality and delivery from identification through close-out. Parexel offers advanced technology and training tailored to your experience, with the potential for less travel and a lower protocol load compared to industry peers. This role offers opportunities for bonus incentives, exposure to multiple therapeutic areas, and career advancement within clinical research. If you are seeking impact, flexibility, and career development, Parexel could be your next professional home.

Requirements

18+ months of direct onsite monitoring experience as a Clinical Research Associate (CRA)
Bachelors or equivalent degree in biological science, pharmacy or other health related discipline.
Strong interpersonal, written, and verbal communication skills within a matrixed team.
Ability to work in a self-driven capacity with a sense of urgency and limited need for oversight.
A client focused approach to work with a flexible attitude with respect to assignments and new learning.
The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).
An honest and ethical work approach to promote the development of life changing treatments for patients.
Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.
Fluency (written & spoken) in both English and French

Responsibilities

Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports.
Oversee the integrity of the study and utilize problem-solving skills to promote rapport with the site and staff.
Review the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are safeguarded and in accordance with the protocol.
Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines.
Ensure compliance with approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and applicable regulatory requirements.
Evaluate the quality and integrity of the reported data, site efficacy, and drug accountability.
Monitor completeness and quality of Regulatory Documentation and perform site document verification.