Job Description

FSP Clinical Research Associate 2 - West Region

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Our FSP team is currently seeking a CRA 2 in West Region with 2 years of monitoring! 8-10 days on site per month being a mix of onsite and remote.

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WHAT YOU WILL DO

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You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

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Responsibilities

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- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned -
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- Responsible for all aspects of site management as prescribed in the project plans
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- General In office Monitoring
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- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
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- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
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- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data
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- Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested
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- Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs
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- Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
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- Assist with training of current employees, eg.



co-monitoring
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- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, ifapplicable) and may act as a local client contact as assigned
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- Perform other duties as assigned by management
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Requirements

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- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
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- 2 years of Clinical Monitoring experience
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- 60% overnight travel
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Fast paced

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where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.

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Changing priorities constantly

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asking you to prioritize and adapt on the spot.

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Teamwork and people skills are essential for the study to run smoothly.

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Technology based

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We collect our data directly into an electronic environment.

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Work is performed in an office environment with exposure to electrical office equipment.

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Frequent travel to clients/ site locations with occasional travel both domestic and international.

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Physical Requirements:

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Ability to sit for extended periods and operate a vehicle safely.

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Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

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Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

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Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

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Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

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Regular and consistent attendance.

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Varied hours may be required.

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Target Pay Range: $100-112K

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#LI - Remote

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Learn more about our EEO & Accommodations request here.

📌 FSP Clinical Research Associate 2 - West Region (Victoria)
🏢 Fortrea
📍 Victoria