Study Start-up Associate – Site Activation Specialist

🔥 2 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Associate

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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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 primary contact with investigative sites during site start-up and maintenance activities • Collect, organize, quality-review, format, compile, and track investigator and essential documents • Ensure EC/IRB/Third body/Regulatory Authority and local applications are submitted within agreed timelines • Provide guidance to sites and authorities regarding submission requirements • Maintain awareness of regulatory legislation, guidance, practice, and current standards • Serve as local expert for project start-up activities in an assigned country or region • Prepare country application forms, cover letters, and routine regulatory submissions such as INDs/CTAs • Liaise with regulatory authorities, internal teams, external vendors, and investigative sites • Review final submission documents and ensure compliance with laws, guidelines, ICH/GCP, SOPs, and quality standards • Track start-up and maintenance activities, milestones, timelines, budgets, and deliverables • Prevent, identify, and escalate study issues and delivery risks • Customize patient informed consent forms for local requirements and protocol compliance • Support negotiation and tracking of site contracts and budgets when applicable • Upload and monitor submission documentation, notifications, and alerts in CTIS for EU studies • Participate in team and project meetings • Mentor and train new hires and less-experienced colleagues when appropriate

🎯 Requirements

• 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) • 2 years' work experience in clinical research, clinical development, or start-up/regulatory process • Strong working knowledge of ICH guidelines and RA, IRB/IEC regulations • Relevant and equivalent experience may be considered in lieu of educational requirements • High School Diploma or equivalent plus a minimum of 2 years' work experience in clinical research may be considered • Working knowledge of applicable regulations and guidelines • Familiarity with investigator start-up documents and contract/budget negotiation processes • Previous interaction with operational project teams and investigative sites • Understanding of research protocol requirements • Ability to communicate and educate others about research protocol requirements • Ability to work in a general office environment

🏖️ Benefits

• Remote work arrangement • Full-time employment