Job Description

Our FSP team is currently seeking experienced CRA 2s located near major hub airports across the US 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 On-Site 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 Reliable 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 new 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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The important thing for us is you are comfortable working in an environment that is:

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Fast paced: 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 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. 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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Applications will be accepted on an ongoing basis.

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Learn more about our EEO & Accommodations request here.

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