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Monitoring Excellence Academy - OMEA - Oncology / CAR T & Alzheimer's - CRA 1

lifelancer·US·United States·mid
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Job Title: Monitoring Excellence Academy - OMEA - Oncology / CAR T & Alzheimer's - CRA 1 Job Location: Remote United States Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Fortrea’s Monitoring Excellence Academy is hiring!! We are seeking strong, Oncology or Ophthalmology Clinical Research Coordinators or Research Nurses with 2+ years of current experience. Must have 2+ years of Oncology, CAR T or Alzheimer's as a CRC or research nurse. Open to various hub locations around the US and French Speaking candidates in Montreal, Canada. Must be willing to travel 65-70%. 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