Senior CRA II - Medical Device Field Lead

Fortrea; Lincoln (NE); Sur place; USD 130 000 - 133 000; Plein temps

Résumé du poste

Fortrea's FSP team is seeking an experienced Senior CRA II based in Central region, with 1+ year device experience and 3+ years of monitoring expertise. You will lead site monitoring activities, ensure compliance with SOPs and regulations, and support project plans as assigned.

Responsibilities include site management, pre-study and initiation visits, trip reports, vendor liaison, data integrity review, and travel up to 60-80% overnight.

Qualifications

• Three (3) years of clinical monitoring experience.
• 1+ year of device experience.
• Fluent in English and local office language.
• Familiarity with regulatory requirements and SOPs.

Responsabilités

• Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaison with vendors.
• Responsible for all aspects of site management as prescribed in the project plans.
• Ensure informed consent procedures and protocol requirements are adhered to according to regulatory requirements.
• Monitor data for missing or implausible data and ensure data integrity.
• Travel, including air travel, may be required and is an essential function of the job.

Connaissances

Clinical monitoring

Formation

University or college degree (life science preferred)

Description du poste

Fortrea's FSP team is seeking an experienced Senior CRA II based in Central region, with 1+ year device experience and 3+ years of monitoring expertise. You will lead site monitoring activities, ensure compliance with SOPs and regulations, and support project plans as assigned.

Responsibilities include site management, pre-study and initiation visits, trip reports, vendor liaison, data integrity review, and travel up to 60-80% overnight.