Iterative Health logo
Iterative Health

Computer vision augmented decisions for gastroenterology

Site Start-Up & Feasibility Specialist

GeneralGeneralFull TimeRemoteSeniorTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

Romania

Posted

3 days ago

Salary

zł188K - zł225.5K / year

Seniority

Senior

Bachelor Degree3 yrs expRomanianEnglishGoogle Cloud Platform

Job Description

Site Start-Up & Feasibility Specialist

Iterative Health

• 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

Job 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

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