Clinical Research Associate II, Phase I

🕒 September 22

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $105k - $118k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 15%

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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 Phase I clinical trials • Respond to emergency situations according to clinical research standards • Monitor clinical study sites, including routine monitoring and close-out visits • Maintain study files and 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 regulatory requirements • Verify integrity of Case Report Form and other data submitted through source-document monitoring • Monitor data for missing or implausible information • Manage registries and conduct feasibility work when requested • Complete Serious Adverse Event reporting, narratives, reports, and follow-up • Perform CRF review, generate and resolve queries using Fortrea or client 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 • Ability to travel overnight 40-50% of the time • Ability to work in a fast-paced, highly regulated clinical research environment • Ability to adapt to 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, fingers, hands, and wrists • Ability to crouch, stoop, bend, and twist upper body and neck • Ability to access and use in-house and off-the-shelf 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 • Ongoing application acceptance

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