Fortrea is looking for a Senior CRA II to join our FSP team. In this remote US role, you will be responsible for site monitoring and management for clinical studies, ensuring compliance with SOPs and regulatory guidelines. You will lead projects of limited scope, act as a Local Project Coordinator or Lead CRA, and travel nationwide.

What You'll Do

Conduct all aspects of study site monitoring including routine visits, closeout, and maintenance of study files.
Liaise with vendors and manage clinical trial supplies.
Ensure study staff have proper materials and instructions for patient enrollment.
Protect study patients by verifying informed consent procedures and protocol adherence.
Ensure data integrity through careful source document review and CRF monitoring.
Maintain audit readiness at the site level and prepare accurate trip reports.
Manage small projects under the direction of a Project Manager/Director.
Serve as lead monitor for a protocol, assist in establishing monitoring plans, and review trip reports.
Review project progress and initiate actions to achieve objectives.
Present at Investigator Meetings and participate in protocol and CRF development.
Interact with internal groups to evaluate needs, resources, and timelines.
Perform registry management as prescribed in project plans and undertake feasibility work.
Conduct, report, and follow up on Quality Control visits.
Recruit investigators, prepare EC submissions, and notify regulatory authorities.
Negotiate study budgets with investigators and assist with statements of agreements.
Track and follow up on Serious Adverse Event reporting.
Independently perform CRF review, query generation, and resolution.
Assist with training and mentoring new employees.
Coordinate designated clinical projects as a Local Project Coordinator and act as a local client contact.

What We're Looking For

A university or college degree (life science preferred), or certification in a related allied health profession.
Thorough knowledge of regulatory requirements and the drug development process.
Fluent in English, both written and verbal.
5+ years of Clinical Monitoring experience.
Full understanding of Serious Adverse Event reporting.
Advanced site monitoring, study site management, and registry administration skills.
Ability to work with minimal supervision and strong planning, organization, and computer skills.
Advanced verbal and written communication skills.
Ability to train junior staff, resolve project problems, prioritize workload, and work within a team.
Ability to work efficiently in a matrix environment.
A valid Driver's License.
Experience in Cardio Device or Electrophysiology.
5+ years of monitoring experience.