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

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 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, 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) - 2+ years as a Study Coordinator or Research Nurse in specified therapeutic areas - Oncology experience is strongly desired ; CAR T a plus - 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