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

Fortrea's FSP team is seeking experienced Central or West Coast based Senior Clinical Research Associates (CRAs) with complex cardiac experience within the past 5 years, preferably in electrophysiology and/or devices. Must have 3+ years of monitoring experience. This role will include some nationwide travel during start up.

Desired Locations: Washington, Oregon, Idaho, California, Montana, Wyoming, Texas, Utah, Arizona, Nevada, New Mexico, Colorado, Kansas, Oklahoma, Nebraska, South Dakota, North Dakota, Minnesota, Wisconsin, Iowa, Missouri, Arkansas, Louisiana, Illinois, Michigan, Indiana

About the Role

The Senior CRA II is responsible for site monitoring and site management for clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures and Regulatory Guidelines. This role may function as a leader for projects of limited scope, assume line management responsibilities, and act as a Local Project Coordinator or Lead CRA as assigned.

Responsibilities

• Perform 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; liaise with vendors; and other duties as assigned.
• Manage all aspects of site management as prescribed in the project plans.
• Ensure study staff have received proper materials and instructions to safely enroll patients into the study.
• Verify protection of study patients by ensuring informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements.
• Ensure data integrity by careful source document review of Case Report Forms (CRFs) or other data collection tools.
• Monitor data for missing or implausible data.
• Manage resources efficiently, including travel expenses, according to Fortrea travel policy.
• Ensure audit readiness at the site level.
• Prepare accurate and timely trip reports.
• Manage small projects under the direction of a Project Manager/Director.
• Serve as lead monitor for a protocol or project and assist in establishing monitoring plans and trip report review.
• Review project progress and initiate appropriate actions to achieve target objectives.
• Organize and present at Investigator Meetings.
• Participate in the development of protocols and Case Report Forms.
• Participate in writing clinical trial reports.
• Interact with internal work groups to evaluate needs, resources, and timelines.
• Act as contact for clinical trial supplies and other vendors.
• Manage all aspects of registry administration as prescribed in the project plans.
• Conduct feasibility work when requested.
• Perform, report, and follow-up on Quality Control (QC) visits.
• Recruit potential investigators, prepare EC submissions, and handle notifications to regulatory authorities.
• Translate study-related documentation and organize meetings as instructed.
• Negotiate study budgets with potential investigators and assist the legal department with statements of agreements.
• Track and follow-up on Serious Adverse Event (SAE) reporting, including processing reports, narratives, and follow-up.
• Independently perform CRF review, query generation, and resolution against established data review guidelines.
• Assist with training, mentoring, and development of new employees, e.g., co-monitoring.
• Coordinate designated clinical projects as a Local Project Coordinator and act as a local client contact as assigned.
• Perform other duties as assigned by management.

Requirements

• 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 international regulatory requirements.
• Thorough understanding of the drug development process.
• Fluent in local office language and English, both written and verbal.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Qualifications

• Three (3) years of Clinical Monitoring experience.
• Full understanding of Serious Adverse Event (SAE) reporting, including process production of reports, narratives, and follow-up.
• Advanced site monitoring and study site management skills.
• Advanced registry administration skills.
• Ability to work with minimal supervision.
• Strong planning and organization skills.
• Good computer skills with proficiency in 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 and in a matrix environment.
• Valid Driver's License.

Physical Demands / Work Environment

• Travel requirements: 60-80% overnight, including air travel, which is an essential function of the job.
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional domestic and international travel.
• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance with varied hours as required.

Pay

Target pay range: $130,000 - $133,000