Remote Senior CRA II — Oncology, Early Phase

Fortrea; Maryland City (MD); À distance; USD 125 000 - 142 000; Plein temps

Résumé du poste

Fortrea is seeking a skilled Clinical Monitor/Local Project Coordinator to ensure high-quality data and patient safety across trial sites. You will perform site monitoring, manage data quality, and support training and coordination with clients. 30-50% overnight travel is required, with a focus on oncology and early-phase studies.

The role demands fast-paced execution, strong teamwork, and adaptability to changing priorities in an electronic data environment.

Qualifications

• 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.
• 30-50% overnight travel.

Responsabilités

• 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

Connaissances

Clinical Monitoring

Oncology experience

Travel readiness

Formation

Bachelor's degree or allied health certification

Description du poste

Fortrea is seeking a skilled Clinical Monitor/Local Project Coordinator to ensure high-quality data and patient safety across trial sites. You will perform site monitoring, manage data quality, and support training and coordination with clients. 30-50% overnight travel is required, with a focus on oncology and early-phase studies.

The role demands fast-paced execution, strong teamwork, and adaptability to changing priorities in an electronic data environment.