Senior Clinical Research Associate II – Ophthalmology

🔥 4 minutes ago

🦞 Maine, New Hampshire, +8 more states – Remote

🦞 Maine – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote 🔔 Pennsylvania – Remote ⚓ Rhode Island – Remote 🍁 Vermont – Remote ⚔️ Virginia – Remote

💵 $125k - $142k / 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

• 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 study 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 • Ensure integrity of data submitted on Case Report Forms and other data collection tools • Monitor source data for missing or implausible information • Manage registries according to project plans and undertake feasibility work when requested • Complete Serious Adverse Event reporting, including reports, narratives and follow-up • Independently perform CRF review and query generation/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 • 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) • 5+ years of Clinical Monitoring experience • Oncology experience; early phase preferred • Ability to undertake 30-50% overnight travel • Ability to work in a fast-paced, deadline-driven, protocol-compliant environment • Ability to prioritize and 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 with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists • Occasional crouching, stooping, 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 15-20 lbs • Regular and consistent attendance • Varied hours may be required

🏖️ Benefits

• 30-50% overnight travel • Ongoing application acceptance