Job Title: Senior Clinical Research Associate I/II (Sr. CRA I/II) – Cardiology/Electrophysiology Device | FSP
Location: Remote – United States (Available in 14 U.S. Locations)
Job Category: Clinical Research / Clinical Operations
Employment Type: Full-Time (FSP Model)
Experience Required: Minimum 3+ years of clinical monitoring experience (Cardiology/Device/Electrophysiology required)
Travel Requirement: 60–80% overnight travel, including nationwide travel during study start-up
Compensation: Target Pay Range: $130,000 – $133,000 annually
About the Organization
Join Fortrea, a leading global Contract Research Organization (CRO) delivering comprehensive clinical development and technology solutions across more than 20 therapeutic areas. Operating in approximately 100 countries, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to accelerate innovation and ensure regulatory compliance across the clinical trial lifecycle.
Through its Functional Service Provider (FSP) model, Fortrea offers strategic clinical operations support embedded within sponsor teams, delivering therapeutic expertise and operational excellence.
Position Overview
Fortrea is seeking experienced Senior Clinical Research Associates (Sr. CRA I or II) with strong expertise in Cardiology, Medical Devices, or Electrophysiology to support U.S.-based clinical trials under the FSP model.
This role is responsible for advanced site monitoring, study site management, regulatory compliance, and leadership of projects with limited scope. The Sr. CRA will function as a Lead CRA or Local Project Coordinator when assigned and may provide mentoring to junior CRAs.
Candidates must have hands-on experience in cardiology device or electrophysiology trials and demonstrate advanced monitoring competencies in complex device studies.
Key Responsibilities
Conduct all aspects of site monitoring, including pre-study visits, site initiation visits (SIV), routine monitoring visits (RMV), and close-out visits (COV)
Ensure compliance with Fortrea and sponsor Standard Operating Procedures (SOPs), ICH-GCP guidelines, and applicable regulatory requirements
Perform comprehensive source document review to ensure data integrity and accurate Case Report Form (CRF) completion
Monitor for missing, inconsistent, or implausible data and resolve queries independently
Oversee Serious Adverse Event (SAE) reporting, including tracking, follow-up, and narrative preparation
Ensure informed consent processes and patient safety standards are strictly followed
Maintain audit readiness at the site level
Manage study site budgets, assist with contract negotiations, and collaborate with legal teams as assigned
Conduct feasibility assessments and support investigator recruitment
Serve as Lead CRA for designated protocols and assist in developing monitoring plans
Prepare accurate and timely monitoring and trip reports
Organize and present at Investigator Meetings
Participate in protocol development, CRF design, and clinical study report writing as assigned
Mentor and train junior CRAs through co-monitoring and structured development
Collaborate cross-functionally within matrixed global teams
Required Qualifications
University or college degree in life sciences (preferred), or certification in an allied health profession such as nursing, medical technology, or laboratory sciences
Minimum 3+ years of independent clinical monitoring experience
Mandatory experience in Cardiology, Electrophysiology, or Medical Device clinical trials
Thorough understanding of global regulatory requirements and ICH-GCP guidelines
Strong knowledge of the drug and medical device development process
Advanced site management and monitoring skills
Proficiency in electronic data capture (EDC) systems and clinical trial software
Strong verbal and written communication skills in English
Valid U.S. Driver’s License
Preferred Competencies
Experience acting as Lead CRA or Local Project Coordinator
Experience managing registry studies
Ability to train and mentor junior staff
Strong project management and organizational skills
Ability to work independently with minimal supervision in a matrix environment
Work Environment
Remote/home-based position within the United States
60–80% overnight travel required, including nationwide travel during study start-up
Occasional domestic and potential international travel
Office-based work involving electronic systems and regulatory documentation
Physical Requirements
Ability to remain stationary for extended periods (6–8 hours per day)
Frequent computer use with repetitive hand and wrist movements
Occasional bending, stooping, and lifting (15–20 lbs, including laptop and travel equipment)
Regular and reliable attendance with flexibility for varied working hours
Why Join Fortrea
Fortrea’s FSP model provides therapeutic specialization, career advancement opportunities, and exposure to complex cardiology and electrophysiology device trials. As a Senior CRA, you will contribute directly to advancing innovative cardiovascular and electrophysiology technologies that improve patient outcomes globally.
This role offers leadership opportunities, strategic project involvement, and the ability to work within a high-performing, collaborative clinical operations environment.
Apply now through ThePharmaDaily.com to advance your career in cardiology and electrophysiology clinical research.
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