Clinical Research Associate II, Phase I

🔥 8 minutes ago

🏄 California – Remote

🏄 California – 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 according to clinical research standards • Conduct 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 to safely enter patients into the study • Verify informed consent procedures and protocol requirements comply with applicable regulatory requirements • Ensure data integrity in Case Report Forms and other data collection tools • Monitor data for missing or implausible data • Manage study registries and undertake feasibility work when requested • Complete Serious Adverse Event reporting, narratives, reports, and follow-up • Perform CRF review and query generation and resolution using Fortrea or client data management systems • Assist with training new employees through co-monitoring • Coordinate designated clinical projects as a Local Project Coordinator, with supervision where applicable • Act as a local client contact when assigned • Perform other duties as assigned by management • 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) • 1+ years of Clinical Monitoring experience • Phase I experience • Ability to undertake 40-50% overnight travel • Comfort 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 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 in-house and off-the-shelf computer software • Ability to lift and carry objects, luggage, and a 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 • Ongoing application acceptance