FSP Senior Clinical Research Associate I / II – Cardiology & Electrophysiology Devices (Remote, USA)
Location: Remote – United States (Nationwide Travel Required)
Category: Clinical Operations
Job ID: 2668
Employment Type: Full-Time
Travel Requirement: 60–80% (Overnight Travel)
Experience Required: Minimum 3+ Years Clinical Monitoring Experience in Cardiology/Device/Electrophysiology
Compensation: Target Pay Range USD 130,000 – 133,000 per year
About the Company
Fortrea is a global contract research organization delivering clinical development solutions to pharmaceutical, biotechnology, and medical device sponsors. Through its Functional Service Provider (FSP) model, Fortrea embeds experienced clinical professionals within sponsor programs to support complex, high-impact studies across therapeutic areas.
Role Overview
Fortrea is seeking experienced Senior Clinical Research Associates (CRA I or II) with specialized expertise in Cardiology, Medical Devices, or Electrophysiology to support sponsor-dedicated programs within the FSP model.
This role requires advanced site monitoring capabilities, strong regulatory knowledge, and direct experience in cardiology device or electrophysiology trials. The position is remote within the United States, with significant nationwide travel, particularly during study start-up phases.
Key Responsibilities
Clinical Site Monitoring & Oversight
Conduct pre-study, site initiation, routine monitoring, and close-out visits
Ensure compliance with sponsor SOPs, ICH-GCP guidelines, and regulatory requirements
Maintain essential study documentation and audit readiness
Perform source document verification (SDV) and CRF review
Identify and resolve data queries within sponsor or CRO systems
Patient Safety & SAE Management
Ensure proper informed consent processes are followed
Track and follow up on Serious Adverse Event (SAE) reporting
Review SAE narratives and ensure regulatory-compliant documentation
Project Leadership & Coordination
Serve as Lead CRA or Local Project Coordinator as assigned
Support monitoring plan development and trip report review
Manage small-scale projects under Project Manager supervision
Present at Investigator Meetings and support protocol development
Contribute to clinical trial reports and feasibility assessments
Regulatory & Operational Activities
Support EC/IRB submissions and regulatory notifications
Negotiate study budgets with investigators as assigned
Coordinate with vendors and clinical trial supply partners
Conduct Quality Control (QC) visits when required
Assist in training, mentoring, and supervising junior CRAs
Educational Qualifications
University degree in Life Sciences preferred, OR
Nursing certification, medical or laboratory technology qualification, OR
Equivalent allied health certification from an accredited institution
Equivalent relevant experience may be considered
Experience & Competency Requirements
Minimum 3 years of clinical monitoring experience
Mandatory experience in Cardiology Device or Electrophysiology trials
Advanced knowledge of SAE processing and reporting requirements
Strong understanding of the drug and medical device development process
Advanced site management and registry administration skills
Ability to work independently with minimal supervision
Strong verbal, written, and presentation skills
Proficiency in clinical trial management systems and standard computer applications
Ability to mentor junior team members
Valid Driver’s License required
Work Environment
Remote/home-based within the United States
60–80% overnight travel, including air travel
Occasional domestic and potential international travel
Technology-driven documentation and monitoring systems
Physical Requirements
Ability to remain stationary for extended periods (6–8 hours daily)
Frequent travel with light equipment (up to 15–20 lbs)
Repetitive computer use and documentation tasks
Flexibility to accommodate varied working hours
Why Consider This Opportunity?
This position offers high-level involvement in advanced cardiology and electrophysiology device trials within a sponsor-dedicated FSP environment. It is suited for senior CRAs seeking leadership responsibilities, therapeutic specialization, and exposure to complex medical device clinical programs.
SEO Keywords:
FSP Senior CRA jobs USA, Cardiology Device CRA remote, Electrophysiology clinical research jobs, Senior CRA cardiology trials, Medical device monitoring careers, Remote CRA jobs United States, FSP clinical research associate cardiology.
Explore more global clinical research and medical device career opportunities at ThePharmaDaily.com.
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