Senior Clinical Research Associate II – Phase I

🔥 0 minutes ago

🐊 Florida – Remote

🐊 Florida – Remote

💵 $115k - $140k / year

⏰ Full Time

🟠 Senior

🧪 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 clinical-trial participants and respond to emergency situations according to clinical research standards • Perform all aspects of study-site monitoring, including routine monitoring and close-out of clinical sites • Maintain study files and conduct pre-study and initiation visits • Liaise with vendors • Manage clinical sites according to project plans • Ensure study staff receive proper materials and instructions to safely enroll patients • Verify informed-consent procedures and protocol requirements comply with applicable regulations • Monitor source documents and data for missing or implausible information • Manage study registries and undertake feasibility work when requested • Complete Serious Adverse Event reporting, reports, narratives, and follow-up • Perform CRF review, query generation, and query resolution in Fortrea or client data-management systems • Assist with training new employees through co-monitoring • Coordinate designated clinical projects as a Local Project Coordinator and act as a local client contact when assigned • Perform other duties as 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, changing-priority, teamwork-oriented, technology-based environment • Ability to sit for extended periods and operate a vehicle safely • Repetitive hand movement of both hands with ability to make fast, simple, repeated movements of fingers, hands, and wrists • Occasional crouching and stooping, with frequent bending and twisting of upper body and neck • Ability to access and use a variety of computer software • Ability to lift and carry objects, luggage, and laptop computer weighing up to 15-20 lbs • Regular and consistent attendance • Varied hours may be required

🏖️ Benefits

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