Oncology - CAR-T - CRA II - Remote US

<p><span class="emphasis-2"><b>We are currently seeking Experienced Oncology CRA 2s to lead and support our Full Service Outsourcing team. CAR-T desired. Open to major hub locations on the East &amp; West Coast. 60-70% travel, 8-10 DOS per month. </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>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 -</li><li>Responsible for all aspects of site management as prescribed in the project plans</li><li>General On-Site Monitoring</li><li>Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study</li><li>Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements</li><li>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</li><li>Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested</li><li>Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of  SAEs</li><li>Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management</li><li>Assist with training of new employees, eg. co-monitoring</li><li>Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned</li><li>Perform other duties as assigned by management</li></ul><p></p><p><b>Requirements</b></p><ul><li>University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)</li><li>1 - 3&#43; years of Clinical Monitoring experience</li><li>Oncology experience is desired</li><li>Open to various hub locations</li></ul><p></p><p>The important thing for us is you are comfortable working in an environment that is:</p><ul><li><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.</li><li><b>Changing priorities constantly</b> asking you to prioritize and adapt on the spot.</li><li><b>Teamwork </b>and<b> people skills</b> are essential for the study to run smoothly.</li><li><b>Technology based</b>. We collect our data directly into an electronic environment.</li></ul><p></p><p><b>What do you get?</b></p><p></p><p>Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:</p><ul><li>Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)</li><li>401(K)</li><li>Paid time off (PTO) – Flex Plan</li><li>Employee recognition awards</li><li>Multiple ERG’s (employee resource groups)</li><li>Target Pay Range (based on title): $105-117K</li></ul><p></p><p><b>Work Environment:</b></p><ul><li><span>Work is performed in an office environment with exposure to electrical office equipment.</span></li><li><span>Frequent travel to clients/ site locations with occasional travel both domestic and international.</span></li></ul><p></p><p><b>Physical Requirements:</b></p><ul><li><span>Ability to sit for extended periods and operate a vehicle safely.</span></li><li><span>Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.</span></li><li><span>Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.</span></li><li><span>Ability to access and use a variety of computer software developed both in-house and off-the-shelf.</span></li><li><span>Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.</span></li><li><span>Regular and consistent attendance.</span></li><li><span>Varied hours may be required.</span></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">EEO &amp; Accommodations request here</a><span>.</span></p>