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Iterative Health

Site Start-Up & Feasibility Specialist

RemotePoland, Romania, Moldova only
Published
Role
Operations
Experience
Senior
Employment
Full-time
Company size
Mid-size
PLN 188k–PLN 225.5k/yr
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Open to PL, RO, MD only. Set where you work from to check your eligibility.

No BS summary

Clinical research specialist needed for site start-up and feasibility in Romania and Moldova. Requires 3+ years of clinical research experience, fluency in Romanian and English, and experience with clinical trial documentation and processes. IBD clinical trial experience is mandatory.

Core skills

site start-upfeasibilityclinical trial documentation

Required skills

clinical researchsite managementclinical research coordinationpharma-sponsored clinical trialssite feasibilitystudy start-up documentationsite communicationregulatory/start-up coordinationIBD clinical trialsICH-GCPsite operationsregulatory documentationSSV/SIV preparationstudy activation requirementstrackerstimelinesaction logsdocument status updatesattention to detailfollow-up skillsrisk flaggingdelay flaggingmissing information flaggingescalation

Optional skills

clinical trial sites in Romania and/or Moldovainvestigatorsstudy coordinatorsSalesforceAsanaCTMS/eTMF platformsExcel/Google SheetsMicrosoft/Google productivity tools

Required languages

RomanianEnglish

What you'll do

  • 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.

What they require

  • 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, etc.

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.

HealthcareMid-size
PLN 188k–PLN 225.5k/yr