Oncology - CRA II & Sr. CRAs
Fortrea
Full-time
Remote friendly (Arizona, United States)
United States
Clinical Research and Development
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Role Summary
Oncology - CRA II & Sr. CRAs
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 monitoring 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
Qualifications
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
- 1 - 3+ years of Clinical Monitoring experience
- Oncology experience is desired
- Open to various hub locations
Skills
- Fast paced environment adaptability
- Strong prioritization and adaptability to changing priorities
- Teamwork and people skills
- Technology-based data collection in an electronic environment
Education
- Not specified beyond the qualifications listed
Additional Requirements
- Travel: 60-70% travel; 8-10 DOS per month
- Location: Open to major hub locations on the East & West Coast
- CAR-T experience desired