Oncology CRA II — Hybrid (Remote/Onsite)

FTINC Fortrea Inc.; North Carolina; Hybride; USD 100 000 - 112 000; Plein temps

Résumé du poste

Fortrea Inc. is seeking a CRA 2 with 2 years of monitoring experience for a hybrid role on the East Coast and Central region. The position requires 60% overnight travel and will involve on-site monitoring 8-10 days per month with remote work as applicable.

The candidate should hold a university degree or allied health certification and be comfortable with clinical trial regulatory standards, data quality, and patient safety.

Qualifications

• 2 years of Clinical Monitoring experience.
• 60% overnight travel.
• University or college degree, or certification in a related allied health profession.

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

Travel readiness

Regulatory knowledge

Formation

University degree or allied health certification

Description du poste

Fortrea Inc. is seeking a CRA 2 with 2 years of monitoring experience for a hybrid role on the East Coast and Central region. The position requires 60% overnight travel and will involve on-site monitoring 8-10 days per month with remote work as applicable.

The candidate should hold a university degree or allied health certification and be comfortable with clinical trial regulatory standards, data quality, and patient safety.