Senior CRA II - Oncology Trials (Remote)

Fortrea; Yorktown (VA); Remote; USD 125,000 - 142,000; Full time

Job summary

Fortrea, based in Virginia, seeks an experienced Clinical Monitor to oversee site monitoring, data integrity, and SAE reporting in oncology trials with 30-50% overnight travel. The role involves coordinating with vendors and site staff, ensuring informed consent, and maintaining study files in a fast-paced environment.

You will train new staff, support local project coordination, and adapt to evolving priorities while ensuring protocol adherence and timely trial milestones.

Qualifications

• University degree or certification in a related allied health profession (e.g. nursing licensure).
• 5+ years of Clinical Monitoring experience.
• Oncology experience, early phase preferred.
• 30-50% overnight travel.

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

Skills

Clinical Monitoring

Travel willingness

Education

University degree or allied health certification

Job description

Fortrea, based in Virginia, seeks an experienced Clinical Monitor to oversee site monitoring, data integrity, and SAE reporting in oncology trials with 30-50% overnight travel. The role involves coordinating with vendors and site staff, ensuring informed consent, and maintaining study files in a fast-paced environment.

You will train new staff, support local project coordination, and adapt to evolving priorities while ensuring protocol adherence and timely trial milestones.