Sr. CRA 2, FSP - Durham - Fortrea

    Fortrea
    Fortrea Durham

    4 days ago

    Description
    Our FSP team is currently seeking a Sr. CRA 2 with 4+ years of monitoring as well as strong Oncology monitoring experience residing on the West Coast.


    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 :

    • 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 -
    • Responsible for all aspects of site management as prescribed in the project plans
    • General On-Site Monitoring
    • 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 the applicable regulatory requirements
    • 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
    • Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested
    • Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs
    • Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
    • Assist with training of new employees, eg. co-monitoring
    • Coordinate designated clinical projects as a Local Project Coordinator (with supervision, ifapplicable) and may act as a local client contact as assigned
    • Perform other duties as assigned by management
    Requirements


    • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
    • 4+ years of Clinical Monitoring experience
    • Oncology experience is required
    • 60-70% overnight travel
    The important thing for us is you are comfortable working in an environment that is:


    • 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.
    • Changing priorities constantly asking you to prioritize and adapt on the spot.
    • Teamwork and people skills are essential for the study to run smoothly.
    • Technology based . We collect our data directly into an electronic environment.

    Work Environment:

    • Work is performed in an office environment with exposure to electrical office equipment.
    • Frequent travel to clients/ site locations with occasional travel both domestic and international.

    Physical Requirements:

    • Ability to sit for extended periods and operate a vehicle safely.
    • 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 (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.
    • Target Pay Range: $115 - $140K
    #LI - Remote
    Applications will be accepted on an ongoing basis.

    Learn more about our EEO & Accommodations request here.
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