Experienced CRA 1 or 2 - Unblinded - West Coast (California, Oregon, Arizona,
Job Title: Experienced CRA 1 or 2 - Unblinded - West Coast (California, Oregon, Arizona,
Job Location: Remote United States
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Our FSP team is currently seeking Unblinded CRAs with 1-3 years of monitoring! Candidates must resided within the United States. 8-10 days on site per month being a mix of onsite and remote. Open to West Coast (California, Oregon, Arizona, Washington, Utah, Colorado, Idaho, etc.) & Texas.
WHAT YOU WILL DO
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.
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
- 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 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 new employees, eg. co-monitoring
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Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
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Perform other duties as assigned by management
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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1+ years of Clinical Monitoring experience
- 50-60% overnight travel
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.
Work 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.
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.
- Regular and consistent attendance.
- Varied hours may be required.
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Target Pay Range: $100-115K based on job title
#LI - Remote
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