Sr. CRA II, Oncology, FSP - Virginia/DC

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<p><span class="emphasis-2"><b>Our FSP team is currently seeking an <u>Oncology Sr. CRA 2 with 5+ years of monitoring</u> residing in Virginia/DC area.</b></span></p><p></p><p><b>WHAT YOU WILL DO</b></p><p></p><p>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.</p><p></p><p><b>Responsibilities</b>:</p><ul><li><p>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 -</p></li><li><p>Responsible for all aspects of site management as prescribed in the project plans</p></li><li><p>General On-Site Monitoring</p></li><li><p>Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study</p></li><li><p>Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements</p></li><li><p>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</p></li><li><p>Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested</p></li><li><p>Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of  SAEs</p></li><li><p>Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management</p></li><li><p>Assist with training of new employees, eg. co-monitoring</p></li><li><p>Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned</p></li><li><p>Perform other duties as assigned by management</p></li></ul><p></p><p><b>Requirements</b></p><ul><li><p>University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)</p></li><li><p>5+ years of Clinical Monitoring experience</p></li><li><p>Oncology experience, early phase preferred</p></li><li><p>40-50% overnight travel</p></li></ul><p></p><p>The important thing for us is you are comfortable working in an environment that is:</p><ul><li><p><b>Fast paced</b>: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.</p></li><li><p><b>Changing priorities constantly</b> asking you to prioritize and adapt on the spot.</p></li><li><p><b>Teamwork </b>and<b> people skills</b> are essential for the study to run smoothly.</p></li><li><p><b>Technology based</b>. We collect our data directly into an electronic environment.</p></li></ul><p></p><p><b>Work Environment:</b></p><ul><li><p>Work is performed in an office environment with exposure to electrical office equipment.</p></li><li><p>Frequent travel to clients/ site locations with occasional travel both domestic and international.</p></li></ul><p></p><p><b>Physical Requirements:</b></p><ul><li><p>Ability to sit for extended periods and operate a vehicle safely.</p></li><li><p>Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.</p></li><li><p>Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.</p></li><li><p>Ability to access and use a variety of computer software developed both in-house and off-the-shelf.</p></li><li><p>Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.</p></li><li><p>Regular and consistent attendance.</p></li><li><p>Varied hours may be required.</p></li><li><p>Target Pay Range: $125 - $140K</p></li></ul><p></p><p>#LI - Remote</p><p>Applications will be accepted on an ongoing basis.</p><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank" rel="noopener noreferrer">EEO & Accommodations request here</a><span>.</span></p>

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