Monitoring Excellence Academy - OMEA - Oncology / CAR T & Gen Meds - CRA 1
About The Position
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 Gen Meds 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%. 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.
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
Nice To Haves
- French Speaking candidates in Montreal, Canada
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 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, 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
Benefits
- Target Pay Range: $80-90K
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
