Clinical Trial Coordinator – Regulatory

🔥 29 minutes ago

🇺🇸 United States – Remote

💵 $65k - $75k / year

⏰ Full Time

🟢 Junior

🚔 Compliance

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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

• Serve as contact for the project team and investigative sites • Conduct and document site contacts for assigned sites according to study guidelines, including creating contact reports for telephone sessions • Monitor site performance and implement action plans with the CRA for sites not meeting expectations • Assist CRAs with site visit preparation by running reports, quality-checking files, and resolving prior action items • Perform Case Report Form review, query generation, and query resolution under supervision on Fortrea or client data management systems • Assist with coordinating study visits and shipment of drug, ancillary supplies, and laboratory kits/samples • Manage sites to ensure subject compliance with protocol requirements, study visits, and timelines • Distribute and track clinical trial supplies and ensure sites have sufficient supplies for recruitment • Coordinate maintenance activities, including amendments and revised documents, for assigned sites • Enter weekly study details in CTMS as required • Assist with submissions and notifications to Ethics Committees and Regulatory Authorities • Facilitate translation and back translation of required documents for local country requirements • Attend and present at investigator, sponsor, kick-off, and face-to-face meetings as needed

🎯 Requirements

• At least one year of experience in a related field, (e.g. medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing) • 1-2 years of clinical research is required • Basic understanding of biology and biological processes • Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP • Good organizational and time management skills • Good communication skills, oral and written • General computer literacy • Ability to work efficiently and effectively in a matrix environment • University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) • 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, with frequent bending and twisting of upper body and neck • Ability to access and use a variety of computer software developed both in-house and off-the-shelf • Light to moderate lifting and carrying objects including luggage and laptop computer with a maximum lift of 15-20 lbs • Regular and consistent attendance • Varied hours may be required

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