Senior CRA II - Medical Device Trials Lead

Fortrea; Sioux Center (IA); On-site; USD 130,000 - 133,000; Full time

Job summary

Fortrea's FSP team is seeking an experienced Senior CRA II based in the Central region with 1+ year of device experience and 3+ years of monitoring experience. The Senior CRA II is responsible for site monitoring and site management for clinical studies, ensuring adherence to SOPs and regulatory guidelines.

Responsibilities include monitoring visits, data integrity checks, travel coordination, and collaborative leadership on projects.

Qualifications

• University or college degree (life science preferred) or equivalent experience.
• Thorough regulatory knowledge and understanding of drug development.
• Fluent in English, both written and verbal.

Responsibilities

• Monitor and manage site activities, visit preparation, and liaise with vendors.
• Lead monitoring plans and trip report reviews on assigned protocols.
• Ensure regulatory compliance and data integrity across CRFs and systems.
• Train and supervise junior staff; coordinate with Project Manager/Director.

Skills

Clinical monitoring

SAE reporting

Site management

Registry administration

Computer skills

Communication skills

Train junior staff

Team collaboration

Driver's license

Education

Life science degree

Related allied health certification

Job description

Fortrea's FSP team is seeking an experienced Senior CRA II based in the Central region with 1+ year of device experience and 3+ years of monitoring experience. The Senior CRA II is responsible for site monitoring and site management for clinical studies, ensuring adherence to SOPs and regulatory guidelines.

Responsibilities include monitoring visits, data integrity checks, travel coordination, and collaborative leadership on projects.