Senior CRA, FSP – Surgical / Medical Device

🔥 13 hours ago

🌽 Illinois, Iowa, +8 more states – Remote

🌽 Illinois – Remote 🌾 Iowa – Remote 🌪️ Kansas – Remote 🌾 Nebraska – Remote 🌶️ New Mexico – Remote 🌪️ Oklahoma – Remote 🚗 Michigan – Remote 🏰 Missouri – Remote 🤠 Texas – Remote 🧀 Wisconsin – Remote

💵 $130k - $133k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 0%

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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

• Monitor and manage clinical study sites, including routine monitoring and closeout visits • Maintain study files and conduct pre-study and initiation visits • Liaise with vendors and manage clinical trial supplies • Ensure study staff receive proper materials and instructions • Verify informed consent procedures and protocol compliance • Review source documents and ensure data integrity on CRFs and other data tools • Monitor missing or implausible data • Perform monitoring tasks efficiently according to SOPs and travel policies • Maintain audit readiness at the site level • Prepare accurate and timely trip reports • Manage small projects under a Project Manager/Director • Serve as lead monitor and assist with monitoring plans and trip report review • Review project progress and initiate actions to achieve objectives • Organize and present at Investigator Meetings • Participate in protocol and Case Report Form development • Participate in writing clinical trial reports • Interact with internal work groups regarding needs, resources, and timelines • Manage registry activities and conduct feasibility work • Conduct, report, and follow up on Quality Control visits • Recruit investigators and prepare ethics committee and regulatory submissions • Translate study documentation and organize meetings • Negotiate study budgets and assist with agreements • Track and follow up on Serious Adverse Event reporting • Perform CRF review, generate and resolve queries in data management systems • Train, mentor, and develop new employees through activities such as co-monitoring • Coordinate clinical projects as a Local Project Coordinator and act as local client contact when assigned • Perform other duties assigned by management

🎯 Requirements

• 1+ year of surgical/medical device experience • 3+ years of clinical monitoring experience • University or college degree, preferably in life science, or certification in a related allied health profession, nursing certification, or medical/laboratory technology certification • Relevant and equivalent experience may be considered in lieu of educational requirements • Thorough knowledge of regulatory requirements, including basic understanding of requirements in other countries • Thorough understanding of the drug development process • Fluency in the local office language and English, written and verbal • Full understanding of Serious Adverse Event (SAE) reporting • 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 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 • Regular and consistent attendance • Ability to travel 60–80% overnight, including occasional domestic and international travel • Ability to perform stated physical requirements, including prolonged stationary work, repetitive hand movements, occasional crouching/stooping, bending/twisting, and lifting 15–20 lbs

🏖️ Benefits

• Remote/home-based work environment • 60–80% overnight travel requirements • EEO and accommodations support