Remote Senior CRA II – Oncology, Early-Phase Trials

Fortrea; Virginia; Remote; USD 125,000 - 142,000; Full time

Job summary

Fortrea is seeking a Clinical Monitoring professional to oversee site monitoring activities for clinical trials from the United States, with potential remote engagement. The role emphasizes adherence to protocol, regulatory compliance, and data integrity across multiple sites.

Candidates should have 5+ years in clinical monitoring, oncology experience (early phase preferred), and be prepared for substantial overnight travel (30-50%).

Qualifications

• 5+ years Clinical Monitoring experience.
• Oncology experience, early phase preferred.
• 30-50% overnight travel required.

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
• 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

Skills

Clinical Monitoring

Oncology experience

Travel readiness

Education

Bachelor's degree or higher

Job description

Fortrea is seeking a Clinical Monitoring professional to oversee site monitoring activities for clinical trials from the United States, with potential remote engagement. The role emphasizes adherence to protocol, regulatory compliance, and data integrity across multiple sites.

Candidates should have 5+ years in clinical monitoring, oncology experience (early phase preferred), and be prepared for substantial overnight travel (30-50%).