Remote Senior CRA II - Ophthalmology/Oncology (Northeast)

Fortrea; New Hampshire; Remote; USD 125.000 - 142.000; Vollzeit

Zusammenfassung

Fortrea is seeking Ophthalmology or Oncology Sr. CRAs with 4+ years of monitoring experience to join our team in the Northeast region of the United States.

This remote-friendly position involves travel up to 50% to sites and vendors, with responsibilities spanning site monitoring, data integrity, and SAE reporting. The role emphasizes clinical judgment, adherence to protocol, and collaboration across cross-functional teams in a fast-paced environment.

Qualifikationen

• University or college degree or related allied health certification.
• 5+ years of Clinical Monitoring experience.
• Oncology experience, early phase preferred.
• Willing to travel 30-50% overnight.

Aufgaben

• Perform all aspects of 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.

Kenntnisse

Clinical Monitoring experience

Oncology monitoring

Overnight travel willingness

Team collaboration

Ausbildung

University or college degree in related allied health

Jobbeschreibung

Fortrea is seeking Ophthalmology or Oncology Sr. CRAs with 4+ years of monitoring experience to join our team in the Northeast region of the United States.

This remote-friendly position involves travel up to 50% to sites and vendors, with responsibilities spanning site monitoring, data integrity, and SAE reporting. The role emphasizes clinical judgment, adherence to protocol, and collaboration across cross-functional teams in a fast-paced environment.