In House Clinical Research Associate II – FSP

🔥 1 minute ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $65k - $72k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 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

• Serve as contact for project teams and investigative sites; conduct and document site contacts • Monitor site performance and implement action plans with the CRA • Track patient recruitment and discuss study risks and opportunities with the Project Manager and CTL • Assist CRAs with site visit preparation, report generation, file QC, and action-item resolution • Oversee site maintenance activities, renewals, and regulatory/IRB/IEC documentation • Perform Case Report Form review, query generation, and resolution in data management systems • Assist with on-site monitoring tasks, including CRF review, SDR/SDV, regulatory files, and drug accountability • Perform remote monitoring visits, including SDV/SDR after MEA training • Liaise with laboratories, sponsors, medical monitors, project teams, CTAs, and sites • Provide site training via phone or web meetings • Conduct IVRS/IWRS review and reconciliation • Coordinate study visits and shipment of drug and laboratory samples • Manage site compliance with protocol requirements, visits, and timelines • Distribute and track clinical trial supplies • Enter weekly study details in CTMS and assist with status reports • Assist with Ethics Committee and Regulatory Authority submissions and notifications • Facilitate translation and back translation of study documents • Attend and present at investigator, sponsor, kick-off, and face-to-face meetings • Ensure compliance with Fortrea SOPs, regulatory requirements, ICH-GCP, and applicable guidelines • Complete the Fortrea Monitoring Excellence Academy training program • Perform other project-related administrative duties as assigned

🎯 Requirements

• University or college degree (biological or life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology) • In lieu of the above requirement, candidates with 2 or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered • Basic understanding of ICH-GCP guidelines • Basic understanding of the clinical trial process • A minimum of 2 years of industry experience in a related role • Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP • Ability to work within a project team • Good planning, organization, time management and problem-solving skills • Good communication skills, oral and written • General computer literacy • Ability to work efficiently and effectively in a matrix environment • Ability to sit for extended periods and operate a vehicle safely • Ability to use a variety of computer software • Light to moderate lifting and carrying of objects up to 15–20 lbs • Regular and consistent attendance • Varied hours may be required

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