FSP Study Start-Up Associate

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $27 - $30 / hour

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 0%

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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 maintenance and assigned site startup activities • Collect, track, quality-review, format, and compile investigator, regulatory, and essential documents • Assist with compiling, preparing, submitting, and obtaining approval of IRB/IEC/Third body/Regulatory Authority documents • Liaise with internal and external vendors regarding Regulatory Authority submissions • Review final submission documents and organize submission/outcome communications within Fortrea • Support compliant site activation and maintenance according to client expectations, ICH/GCP, SOPs, budget, quality, laws, and guidelines • Update study documents, status reports, logs, tracking systems, and systems of record • Adapt Informed Consent Forms and patient-facing materials to country-specific requirements • Support contract negotiation under supervision • Identify and escalate risks, study issues, out-of-scope hours, and budget over-burn • Upload submission documentation to CTIS under supervision, where applicable • Coordinate support-function operations, stakeholders, internal teams, project status, financial information, standards, budgets, timelines, and resources • Support Clinical Operations compliance, vendor oversight, study operating models, business processes, systems, quality initiatives, and training activities as assigned • Provide oversight and direction to team members for functional and study-related deliverables • Support and implement global and country-level feasibility, study startup, site activation, and regulatory and ethics document preparation and submission

🎯 Requirements

• BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience, or advanced degree • Minimum 0–2+ years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job • Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines • Demonstrated basic understanding of the clinical trial process • Knowledge of clinical trial conduct, including multi-center, global trials • Strong knowledge of ICH/GCP guidelines and regulatory requirements • Proven project management skills and leadership ability • Excellent interpersonal, written and verbal communication skills • Administrative skills and computer ability • Fluent in English • Minimal (10–15%) travel required

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Life insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(K) • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable