Study Start-Up Specialist

Job not on LinkedIn

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $60k - $70k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

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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 the 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 investigative sites and regulatory authorities regarding submission requirements • Maintain awareness of current regulatory legislation, guidance, practices, ICH/GCP, SOPs, and quality standards • Coordinate and prepare country application forms, cover letters, informed consent forms, and routine regulatory submissions such as INDs/CTAs • Review and negotiate informed consent forms with sites and resolve related issues • Liaise with internal and external vendors and regulatory authorities regarding submissions and approvals • Ensure start-up and maintenance activities remain on track, within budget, and compliant with applicable requirements • Identify, prevent, escalate, and communicate study risks and issues • Participate in team and project meetings • Assist with site activation strategy, projections, timelines, site contracts, and budgets as applicable • Upload and monitor submission documentation, notifications, alerts, milestones, and events in CTIS for EU studies • Mentor and train new hires and less-experienced colleagues as appropriate

🎯 Requirements

• University/College degree in 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 • High School Diploma or equivalent may qualify with the required experience • Minimum of 2 years of work experience in clinical research, clinical development, or start-up/regulatory processes • Strong working knowledge of ICH guidelines and RA, IRB/IEC regulations • 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 and ability to communicate and educate others about them • Ability to maintain compliance with applicable laws, guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards • Ability to collect, track, review, format, compile, and file high-quality regulatory and site documents • Knowledge of Clinical Trials Information System (CTIS) tasks for applicable EU studies

🏖️ Benefits

• Medical • Dental • Vision • Life insurance • STD/LTD • 401(K) • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable