CRA 2 - Late Phase (Eastern or Western Canada)


Ensure clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements by engaging with assigned sites.


May perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions.

Complete appropriate therapeutic, protocol and clinical research training to perform job duties.

Work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.

Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.

Execute assigned work efficiently and adhere to project timelines and financial goals

Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.

May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities.


Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint

Strong written and verbal communication skills in applicable languages, and business level command of English

Good organizational, interpersonal and problem-solving skills

Strong attention to detail

Working time management skills

Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites


Bachelor’s Degree preferably in life science, and 2 years of monitoring experience; or equivalent combination of education, training and experience


Extensive use of telephone and face to face communication requiring accurate perception of speech

Extensive use of keyboard requiring repetitive motion of fingers

Regular sitting for extended periods of time

Frequent travel to sites

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