Sr. CRA 2, Oncology, FSP - Midwest

Job Description Our FSP team is currently seeking an Oncology Sr. CRA2 with 5+ years of monitoring residing in the Midwest (IL, IN, IA, KS, MI, MN, MO, ND, SD, WI, OH) area. 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. 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. 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 monitoring. 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 reports, 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, e.g., co‑monitoring. Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) 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). 5+ years of clinical monitoring experience. Oncology experience, early phase preferred. 40–50% overnight travel. Comfortable working in an environment that is fast‑paced, with no deviations from the study protocol allowed, and changing priorities constantly. Work Environment Work is performed in an office environment with exposure to electrical office equipment. Frequent travel to clients/site locations with occasional domestic and international travel. 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 of objects including luggage and laptop computer with a maximum lift of 15–20lbs. Regular and consistent attendance. Varied hours may be required. Target Pay Range: $125–$140K Remote applications will be accepted on an ongoing basis. EEO & Accommodations request: Learn more about our EEO & Accommodations request. #J-18808-Ljbffr