Senior CRA, FSP - Cardiac / Medical Device

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🔥 8 minutes ago

🏄 California, Iowa, +2 more states – Remote

🏄 California – Remote 🌾 Iowa – Remote 🚗 Michigan – Remote ❄️ Minnesota – Remote

💵 $130k - $133k / year

⏰ Full Time

🟠 Senior

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Perform all aspects of study site monitoring, including routine monitoring and closeout of clinical sites • Maintain study files and conduct pre-study and initiation visits • Liaise with vendors and manage site management activities according to project plans • Ensure study staff have proper materials and instructions to safely enter patients into the study • Verify informed consent procedures and protocol requirements to protect study patients • Review source documents and monitor CRFs and other data collection tools for data integrity • Monitor missing or implausible data and 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 with monitoring plans and trip report review • Review project progress and initiate actions to achieve target objectives • Organize and present at Investigator Meetings • Participate in protocol, Case Report Form, and clinical trial report development • Interact with internal work groups to evaluate needs, resources, and timelines • Act as contact for clinical trial supplies and other suppliers • Manage clinical trial registries and undertake feasibility work • Conduct, report, and follow up on Quality Control visits • Recruit potential investigators and prepare EC submissions and regulatory notifications • Translate study documentation and organize meetings as assigned • Negotiate study budgets and assist Fortrea legal with statements of agreements • Track and follow up on Serious Adverse Event reporting and produce related reports and narratives • Perform CRF review, query generation, and query resolution in data management systems • Assist with training, mentoring, and development of new employees • Coordinate designated clinical projects as a Local Project Coordinator and act as a local client contact as assigned • Perform other duties assigned by management

🎯 Requirements

• Central or West Coast based • Complex cardiac experience within the past 5 years, preferably in electrophysiology and/or devices • 3+ years of clinical monitoring experience • University or college degree in life science preferred, or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology • Relevant and equivalent experience may be considered in lieu of educational requirements • Thorough knowledge of regulatory requirements, including a basic understanding of regulatory requirements in other countries • Thorough understanding of the drug development process • Fluent in the local office language and in English, written and verbal • Full understanding of Serious Adverse Event reporting, report production, narratives, and SAE follow-up • 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 and 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 and matrix environment • Valid Driver's License • 60–80% overnight travel requirement • Ability to travel domestically and internationally • Ability to remain stationary for 6–8 hours per day • Ability to perform repetitive hand movements • Ability to crouch, stoop, bend, and twist • Ability to lift and carry luggage and a laptop weighing 15–20 lbs • Regular and consistent attendance; varied hours may be required

🏖️ Benefits

• Target Pay Range: $130-133K • Office/Home-Based work environment • Fortrea travel policy for economical travel expenses