Start-up Specialist

🕒 September 23

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

👻 Ghost score 11%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 study start-up and maintenance • Collect, organize, quality-review, format, compile, and file investigator and essential study documents • Coordinate EC/IRB/Third body/Regulatory Authority applications and submissions within agreed timelines • Prepare country application forms, cover letters, and routine submissions such as INDs/CTAs • Liaise with regulatory authorities, internal teams, external vendors, and investigative sites • Review final submission documents and ensure compliance with regulations, ICH/GCP, SOPs, quality standards, budgets, and client expectations • Track start-up, maintenance, site activation, contract, and budget activities and milestones • Identify, prevent, and escalate study issues and risks to deliverables • Maintain systems and documentation in an audit-ready state • Participate in team and project meetings • Assist with site activation strategy, projections, and timelines • Review and customize country- and site-specific informed consent forms • Support negotiation and tracking of site contracts and budgets when applicable • Mentor and train new hires and less-experienced colleagues when suitable • Perform other duties as assigned

🎯 Requirements

• Residing in the United States • University/College degree in a relevant field (life science preferred), or certification in a related allied health profession from an appropriate accredited institution • Relevant and equivalent experience may be considered in lieu of educational requirements • Alternatively, High School Diploma or equivalent plus at least 2 years of clinical research experience • Minimum 2 years of experience in clinical development or start-up/regulatory processes • Strong working knowledge of ICH guidelines and RA, IRB/IEC, and other applicable regulations/guidelines • Familiarity with investigator start-up documents and contract/budget negotiation processes • Previous interaction with operational project teams and investigative sites • Demonstrated understanding of research protocol requirements and ability to communicate/educate others about them • Ability to work in a fast-paced, constantly changing, technology-based environment • Ability to sit for extended periods and operate a vehicle safely • Ability to perform repetitive hand movements and occasional crouching, stooping, bending, and twisting • Ability to use various computer software • Ability to lift/carry 15–20 lbs • Regular and consistent attendance • Varied hours may be required

🏖️ Benefits

• Frequent travel to clients/site locations with occasional domestic and international travel • Ongoing application acceptance