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 ensures the implementation of project plans, acts as a leader for projects of limited scope, and may assume line management responsibilities or serve as a Local Project Coordinator or Lead CRA.

Responsibilities

• Perform all aspects of study site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, and conduct of pre-study and initiation visits.
• Liaise with vendors and perform other duties as assigned.
• Ensure study staff are properly trained and equipped to safely enroll patients.
• Verify adherence to informed consent procedures and protocol requirements to protect study patients.
• Ensure data integrity through careful source document review and monitoring of Case Report Forms (CRFs) or other data collection tools.
• Identify and address missing or implausible data.
• Manage resources efficiently, including travel expenses, according to Fortrea’s 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, including establishing monitoring plans and reviewing trip reports.
• Review project progress and initiate actions to achieve target objectives.
• Organize and present at Investigator Meetings.
• Participate in protocol and Case Report Form development as assigned.
• Contribute to writing clinical trial reports.
• Evaluate project needs, resources, and timelines with internal teams.
• Act as a contact for clinical trial supplies and vendors.
• Manage all aspects of registry administration as prescribed in project plans.
• Conduct feasibility work and Quality Control (QC) visits as requested.
• Recruit potential investigators and prepare Ethics Committee (EC) submissions.
• Assist with notifications to regulatory authorities and translation of study-related documentation.
• Negotiate study budgets with investigators and assist the legal department with agreements.
• Track and follow up on Serious Adverse Event (SAE) reporting, including narratives and follow-ups.
• Perform independent CRF review, query generation, and resolution using Fortrea or client data management systems.
• Train, mentor, and develop new employees, including co-monitoring.
• Coordinate designated clinical projects as a Local Project Coordinator and act as a local client contact.
• Perform other duties as assigned by management.

Requirements

• University or college degree (life science preferred), or certification in a related allied health profession (e.g., nursing, medical, or laboratory technology).
• Thorough knowledge of regulatory requirements, including a basic understanding of international regulations.
• Fluent in English and the local office language, both written and verbal.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Qualifications

• Three (3) or more years of clinical monitoring experience.
• Full understanding of Serious Adverse Event (SAE) reporting, including narratives and follow-ups.
• Advanced site monitoring and study site management skills.
• Advanced registry administration skills.
• Ability to work with minimal supervision and strong planning/organization skills.
• Proficiency with a range of computer packages.
• Advanced verbal and written communication skills.
• Ability to train and supervise junior staff.
• Problem-solving skills and ability to prioritize workload for self and team.
• Ability to work efficiently in a matrix environment.
• Valid Driver’s License.

Physical Demands / Work Environment

• Travel requirements: 60-80% overnight, including domestic and occasional international travel.
• Work is primarily performed in an office or home-based environment with exposure to electrical office equipment.
• Occasional drives to site locations.
• Frequently stationary for 6-8 hours per day.
• Repetitive hand movements, including typing and use of computer peripherals.
• Occasional crouching, stooping, bending, and twisting of the upper body and neck.
• Light to moderate lifting (15-20 lbs), such as luggage or a laptop.
• Regular and consistent attendance with varied hours as required.

Pay

Target pay range: $130,000–$133,000 (based on title).