FSP In-House CRA II

🔥 18 hours ago

🇺🇸 United States – Remote

💵 $68k - $70k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 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, including contact reports for telephone sessions • Monitor site performance and implement action plans with the CRA • Collaborate during recruitment, track patient recruitment, and discuss study risks and opportunities • Assist CRAs with site visit preparation, report running, file QC, and action-item resolution • Provide oversight and management of site maintenance activities and regulatory renewals • Perform Case Report Form review and query generation and resolution in data management systems • Assist with on-site monitoring tasks, including CRF review, SDR/SDV, Site Regulatory File review, and drug accountability • Perform remote visits and remote monitoring requiring SDV/SDR after MEA training • Liaise with laboratories, sponsors, medical monitors, project teams, and CTAs • Provide site training via phone, teleconference, or web meeting • Conduct IVRS/IWRS review and reconciliation • Coordinate study visits and shipment of drug and laboratory samples • Manage sites to ensure protocol compliance, study 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 documents • Attend and present at investigator, sponsor, kick-off, and face-to-face meetings • Ensure compliance with Fortrea SOPs, local regulations, ICH-GCP, and applicable guidelines • Perform other assigned project-related administrative duties

🎯 Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution • Biological or life science degree preferred • Nursing licensure, medical technology, or laboratory technology certification examples • In lieu of the degree or certification, 2 or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered • Minimum of 2 years of industry experience in a related role • Basic understanding of ICH-GCP guidelines • Basic understanding of the clinical trial process • 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 access and use a variety of computer software • Regular and consistent attendance • Varied hours may be required

🏖️ Benefits

• Remote work arrangement • Training through the Fortrea Monitoring Excellence Academy (MEA) • Domestic and international travel opportunities