Site Start-Up Specialist

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🕒 5 days ago

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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 the primary contact for investigative sites during start-up and maintenance activities • Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority) • Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications • Prepare and submit regulatory documents, including country-specific application forms and informed consent forms • Track submission timelines and proactively address potential delays • Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities • Ensure all documentation is audit-ready and systems are consistently updated • Assist in the negotiation of site contracts and budgets, if applicable • Provide mentorship and training to new hires and less-experienced colleagues

🎯 Requirements

• University/College degree (life sciences preferred) or certification in a related allied health profession • Minimum 2 years of experience in clinical research, regulatory submissions, or site activation • Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes • Ability to review and adapt patient informed consent forms to meet local and protocol-specific requirements • Experience interacting with regulatory authorities and site start-up teams • Excellent organizational, problem-solving, and communication skills • Proficiency in Microsoft Office and document management systems

🏖️ Benefits

• Competitive salary and performance-based incentives • Flexible work arrangements (remote/hybrid options) • Professional growth opportunities in a collaborative and innovative environment • The opportunity to work on cutting-edge clinical research projects