Senior CRA II, Ophthalmology - Remote/Travel

Fortrea; United States; Remote; USD 125.000 - 142.000; Vollzeit

Zusammenfassung

Fortrea is seeking a Senior Clinical Research Associate II for Ophthalmology in the Northeast. The role focuses on on-site monitoring, site management, and ensuring protocol compliance across clinical trial sites with global data management integration.

The successful candidate will bring 5+ years of clinical monitoring experience, a university degree or allied health certification, and oncology exposure, with 30-50% overnight travel expected to support study activities in the United States.

Qualifikationen

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution.
• 5+ years of Clinical Monitoring experience.
• Oncology experience, early phase preferred.
• 30-50% overnight travel.

Aufgaben

• 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, ifapplicable) and may act as a local client contact as assigned
• Perform other duties as assigned by management

Kenntnisse

Clinical Monitoring

Oncology experience

Overnight travel

Ausbildung

University or college degree, or certification in a related allied health profession

Jobbeschreibung

Fortrea is seeking a Senior Clinical Research Associate II for Ophthalmology in the Northeast. The role focuses on on-site monitoring, site management, and ensuring protocol compliance across clinical trial sites with global data management integration.

The successful candidate will bring 5+ years of clinical monitoring experience, a university degree or allied health certification, and oncology exposure, with 30-50% overnight travel expected to support study activities in the United States.