Clinical Research Associate II, Phase I

🔥 12 hours ago

⛰️ Colorado, Kansas, +3 more states – Remote

⛰️ Colorado – Remote 🌪️ Kansas – Remote 🌾 Nebraska – Remote 🏰 Missouri – Remote 🤠 Texas – Remote

💵 $100k - $120k / 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

• Provide a high standard of care for participants in clinical trials • Respond to emergency situations based upon clinical research standards • Perform routine monitoring and close-out of clinical sites • Maintain study files • Conduct pre-study and initiation visits • Liaise with vendors • Manage study sites according to project plans • Ensure study staff receive proper materials and instructions • Verify informed consent procedures and protocol requirements comply with applicable regulations • Monitor source documents and verify the integrity of CRF and other collected data • Manage clinical registries and undertake feasibility work • Complete Serious Adverse Event reporting, narratives, reports, and follow-up • Perform CRF review and generate and resolve queries in data management systems • Assist with training new employees through co-monitoring • Coordinate designated clinical projects as a Local Project Coordinator • Act as a local client contact when assigned • Perform other duties assigned by management

🎯 Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) • 1+ years of Clinical Monitoring experience • Phase I experience • Comfortable working in a fast-paced environment with strict study protocol and timelines • Ability to adapt to constantly changing priorities • Teamwork and people skills • Comfort working in a technology-based electronic data environment • Ability to sit for extended periods and operate a vehicle safely • Repetitive hand movement of both hands and ability to make fast, simple, repeated movements of the fingers, hands, and wrists • Ability to crouch, stoop, bend, and twist the upper body and neck • Ability to access and use a variety of computer software • Ability to lift and carry 15-20 lbs • Regular and consistent attendance • Varied hours may be required

🏖️ Benefits

• Remote work arrangement • 40-50% overnight travel • Occasional domestic and international travel • Ongoing application acceptance