Site Start-Up & Feasibility Specialist

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Iterative Health

WebsiteLinkedInAll Job Openings

51 - 200 employees

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

🧬 Biotechnology

Artificial Intelligence • Healthcare Insurance • Biotechnology

Iterative Health is a company focusing on revolutionizing gastrointestinal (GI) care through advances in artificial intelligence and machine learning. They aim to optimize clinical trials and empower physicians with AI tools, particularly for colorectal cancer screening and surveillance. Their mission is to bring precision GI care worldwide by developing a complete ecosystem using cutting-edge technology. Iterative Health combines services and technology to enhance clinical research practices and has been recognized in the field of gastroenterology for its pioneering work and collaboration with leading scientists.

📋 Description

• Support the collection and maintenance of information on qualified IBD clinical trial sites in Romania and Moldova. • Help keep site capability information up to date, including investigator experience, patient access, and basic operational readiness. • Support feasibility activities by helping coordinate CDA execution, collecting site input, and assisting with feasibility questionnaires. • Review feasibility responses for completeness and consistency before internal or CRO/sponsor review. • Help prepare feasibility information for CROs, sponsors, and internal stakeholders. • Track feasibility status, open questions, and next steps. • Support site start-up activities from feasibility through regulatory and contractual readiness, SSV/SIV preparation, activation, and early recruitment readiness. • Collect, organize, and quality-check site-level documents using CRO and sponsor templates. • Check documents for missing items, expired credentials, formatting issues, and basic inconsistencies before submission. • Help prepare sites for selection visits and initiation visits by sharing document requirements, timelines, and expectations. • Attend site visits when requested and appropriate. • Maintain start-up checklists and trackers under the guidance of internal team members. • Flag blockers or delays early and escalate them to the appropriate internal contact. • Support activation planning and help sites prepare for patient screening activities after regulatory approval. • Serve as a day-to-day operational contact for sites in Romania and Moldova during feasibility and study start-up. • Coordinate site questions and route them to the appropriate internal, CRO, or sponsor contact when needed. • Communicate with PIs, study coordinators, site staff, CRO start-up teams, and internal stakeholders. • Help sites understand Iterative Health services, tools, checklists, and workflows. • Maintain clear, professional, and timely communication with sites and study partners. • Maintain accurate updates in Salesforce, Asana, study trackers, and other relevant systems. • Track action items, document status, owners, due dates, and follow-up items. • Support basic reporting on feasibility turnaround, document completion, SSV/SIV readiness, activation timelines, and site responsiveness. • Help identify recurring document or start-up issues and share them with the internal team. • Follow established processes and contribute suggestions for improvement when appropriate. • Perform related duties as requested

🎯 Requirements

• Minimum of 3 years of experience in clinical research, preferably in a CRO, site start-up, feasibility, site management, or clinical research coordination role. • Experience supporting pharma-sponsored clinical trials, preferably Phase 2–4 studies. • Experience with site feasibility, study start-up documentation, site communication, or regulatory/start-up coordination. • IBD clinical trial experience is required. • Basic understanding of ICH-GCP, site operations, regulatory documentation, SSV/SIV preparation, and study activation requirements. • Experience working with clinical trial sites in Romania and/or Moldova is preferred. • Ability to maintain trackers, timelines, action logs, and document status updates accurately. • Strong attention to detail and consistent follow-up skills. • Ability to flag risks, delays, or missing information and escalate appropriately. • Fluency in Romanian and English is required, both written and spoken. • Bachelor’s degree in life sciences, healthcare, pharmacy, nursing, biotechnology, public health, or a related field is preferred. • Willingness to travel within Romania and Moldova for site visits as needed. • Future travel to additional Balkan countries may be required if the regional network expands.

🏖️ Benefits

• Private medical coverage • Life insurance • Retirement benefits • Paid time off