Fortrea's FSP team is seeking experienced Senior CRAs based in Canada with complex cardiac experience within the past 5 years, preferably in electrophysiology and/or devices. Must have 3+ years of monitoring experience. This role will include some nationwide travel during start up.

Job Overview

The Senior CRA II is responsible for site monitoring and site management. Responsibilities include ensuring compliance with Fortrea and sponsor SOPs and regulatory guidelines. The Senior CRA I will help implement project plans, lead limited scope projects, assume line management duties, and act as Local Project Coordinator or Lead CRA as needed.

Summary of Responsibilities

- The statements below describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.
- Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre‑study and initiation visits; liaise with vendors; and other duties, as assigned.
- Responsible for all aspects of site management as prescribed in the project plans.
- General On‑Site Monitoring Responsibilities:
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements.
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
- Monitor data for missing or implausible data.
- Ensure that sponsor and Fortrea resources are used wisely by performing required monitoring tasks efficiently, according to SOPs and established guidelines, including managing travel expenses in an economical fashion.
- Ensure audit readiness at the site level.
- Travel, including air travel, may be required and is an essential function of the job.
- Prepare accurate and timely trip reports.
- Manage small projects under the direction of a Project Manager/Director, as assigned.




- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review, as assigned.
- Review progress of projects and initiate appropriate actions to achieve target objectives.
- Organize and make presentations at investigator meetings.
- Participate in the development of protocols and Case Report Forms, as assigned.
- Participate in writing clinical trial reports, as assigned.
- Interact with internal work groups to evaluate needs, resources, and timelines.
- Act as contact for clinical trial supplies and other suppliers (vendors), as assigned.
- Responsible for all aspects of registry management as prescribed in the project plans.
- Undertake feasibility work when requested.
- Conduct, report, and follow‑up on Quality Control (QC) visits when requested.
- Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study‑related documentation, organize meetings and other tasks as instructed by supervisor.
- Negotiate study budgets with potential investigators and assist the Fortrea legal department with agreements, as assigned.
- Track and follow‑up on Serious Adverse Event (SAE) reporting, production of reports, narratives and follow‑up of SAEs.
- Independently perform CRF review; generate and resolve queries against established data review guidelines on Fortrea or client data management systems, as assigned.
- Assist with training, mentoring and development of new employees, e.g., co‑monitoring.
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact, as assigned.
- Perform other duties as assigned by management.
- All other duties as needed or assigned.

Qualifications (Minimum Required)

- University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification,



medical or laboratory technology.
- Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries.
- Thorough understanding of the drug development process.
- Fluent in local office language and in English, both written and verbal.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required)

- Three (3) years of clinical monitoring experience.
- Have a full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow‑up of SAEs.
- Advanced site monitoring skills.
- Advanced study site management skills.
- Advanced registry administration skills.
- Ability to work with minimal supervision.
- Good planning and organization skills.
- Positive computer skills with good working knowledge of a range of computer packages.
- Advanced verbal and written communication skills.
- Ability to train and supervise junior staff.
- Ability to resolve project‑related problems and prioritize workload for self and team.
- Ability to work within a project team.
- Works efficiently and effectively in a matrix environment.
- Valid Driver's License.

Physical Demands / Work Environment

- Travel requirements: 60–80% overnight.

Office/Home‑Based

- Work is performed in an office environment with exposure to electrical office equipment.
- Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements

- Frequently stationary for 6–8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in‑house and off‑the‑shelf.
- Light to moderate lifting and carrying of objects including luggage and laptop computer with a maximum lift of 15–20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.

EEO & Accommodations: Learn more about our EEO & Accommodations request here.

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📌 Sr. CRA, FSP - Cardiac & Medical Device - Canada (Toronto)
🏢 Fortrea
📍 Toronto