other
Posted 3 hours agoSite Start-Up & Feasibility Specialist
Romania Or Poland, RomaniaOn-site
Responsibilities
- Support the collection and maintenance of information on qualified IBD clinical trial sites in Romania and Moldova.
- 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.
- Track feasibility status, open questions, and next steps. Site Start-Up & Activation Support
- 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.
- Maintain start-up checklists and trackers under the guidance of internal team members.
- Support activation planning and help sites prepare for patient screening activities after regulatory approval. Site Communication & Coordination
- Coordinate site questions and route them to the appropriate internal, CRO, or sponsor contact when needed.
- Maintain clear, professional, and timely communication with sites and study partners. Tracking, Documentation & Process Support
- 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.
- Perform related duties as requested What You Bring to the Team
Requirements
- By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need.
- Fluency in Romanian and English are required, both written and spoken.
- Help keep site capability information up to date, including investigator experience, patient access, and basic operational readiness.
- 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.
- 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.
- experience supporting IBD clinical trials at a CRO, sponsor, or clinical research site. •
- Experience working with investigators and study coordinators. •
- Experience with Salesforce, Asana, CTMS/eTMF platforms, Excel/Google Sheets, and Microsoft/Google productivity tools.
- Familiarity with EDC systems. •
- Experience supporting multiple clinical trial sites. •
- Experience working in remote or international teams. What Success Looks Like
Benefits
- Location : Remote: Poland or Romania with travel Employment Type: Full-Time EOR Compensation: PLN 188,000 – PLN 225,500 gross annual base salary or RON 216,000 - RON 259,000 plus annual bonus and benefits.
- Final compensation will be determined based on experience, skills, and internal equity.
- Benefits: Private medical coverage, life insurance, retirement benefits, paid time off, etc.
Contact
- experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Additional details
- Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.
- We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
- Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.
- As a Site Start-Up & Feasibility Specialist at Iterative Health, you will support feasibility and study start-up activities for our clinical research site network in Romania and Moldova.
- This role will focus on coordinating documents, supporting site communication, tracking start-up activities, and helping sites prepare for IBD clinical trials.
- You will work with sites in Romania and Moldova, investigators, CROs, sponsors, and internal Iterative Health teams to help move studies from feasibility through site activation.
- As the network grows, the role may also support additional countries in the Balkans.
- This is a hands-on operational role for someone who is organized, detail-oriented, comfortable working with clinical trial documentation, and able to follow established processes.
- The role is suited for someone who has clinical research
- experience and wants to further develop in feasibility and site start-up.