Senior Clinical Research Associate II - Oncology

🕒 September 25

🏈 Ohio – Remote

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💵 $125k - $140k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 1%

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Logo of Fortrea

Fortrea

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 oncology clinical trials and respond to emergency situations based on clinical research standards • Conduct routine monitoring and close-out of clinical sites • Maintain study files and conduct pre-study and initiation visits • Liaise with vendors and perform other assigned duties • 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 • Ensure the integrity of submitted Case Report Forms and other data collection tools through source-document review • Monitor data for missing or implausible information • Manage registries and undertake feasibility work when requested • Complete Serious Adverse Event reporting, reports, narratives, and follow-up • Perform CRF review, generate and resolve queries using Fortrea or client data management systems • Assist with training new employees through activities such as co-monitoring • Coordinate designated clinical projects as a Local Project Coordinator and may act as a local client contact • Travel frequently to client and site locations, including occasional domestic and international travel

🎯 Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) • 5+ years of Clinical Monitoring experience • Oncology experience; early phase preferred • Ability to undertake 30–50% overnight travel • Comfort working in a fast-paced, constantly changing, technology-based environment • Teamwork and people skills • Ability to sit for extended periods and operate a vehicle safely • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists • Occasional crouching and stooping, with frequent bending and twisting of the upper body and neck • Ability to access and use a variety of computer software developed both in-house and off-the-shelf • Ability to lift and carry objects including luggage and a laptop computer, with a maximum lift of 15–20 lbs • Regular and consistent attendance • Availability to work varied hours

🏖️ Benefits

• Remote work designation • 30–50% overnight travel opportunities • Ongoing application acceptance

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