Sr. CRA, FSP - Cardiac / Medical Device - West Coast

Job Overview

The Senior CRA II is responsible for site monitoring and site management. Responsibilities include clinical studies according to Fortrea and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The role includes some nationwide travel during startup.

Summary Of Responsibilities

• Ensure study staff receive proper materials and instructions for patient entry into the study.
• Verify adherence to informed consent procedures and protocol requirements.
• Review and ensure the integrity of data submitted on Case Report Forms (CRFs).
• Maintain study files and manage travel expenses.
• Assure audit readiness at the site level.
• Prepare accurate and timely trip reports.
• Manage small projects under the direction of a Project Manager/Director.
• Organize and present at Investigator Meetings.
• Participate in the development of protocols and Case Report Forms.
• Write clinical trial reports.
• Evaluate needs, resources, and timelines within internal work groups.
• Contact for clinical trial supplies and other suppliers.
• Undertake feasibility work and conduct Quality Control (QC) visits.
• Track and follow-up on Serious Adverse Event (SAE) reporting.
• Perform CRF review, query generation, and resolution.
• Train, mentor, and develop new employees.
• Coordinate designated clinical projects as a Local Project Coordinator.
• Resolve project-related problems and prioritize workload.
• Work efficiently and effectively in a matrix environment.
• Perform other duties as assigned by management.

Qualifications (Minimum Required)

• University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
• Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process.
• Fully fluent in local office language and in English, both written and verbal.
• Valid Driver's License.

Experience (Minimum Required)

• Three (3) years of Clinical Monitoring experience.
• Advanced site monitoring skills.
• Advanced study site management skills.
• Advanced registry administration skills.
• Ability to work with minimal supervision.
• Good planning and organization skills.
• Good computer skills with good working knowledge of a range of computer packages.
• Advanced verbal and written communication skills.
• Ability to train and supervise junior staff.
• Ability to resolve project-related problems and prioritize workload for self and team.
• Ability to work within a project team.
• Works efficiently and effectively in a matrix environment.

Physical Demands/Work Environment

• Travel requirements: 60-80% overnight.
• Office/Home-Based Work Environment: Exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestically and internationally.
• Frequent bending, twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

Target Pay Range (based on title)

$130-133K