Site Start-Up & Feasibility Specialist

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.

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.

Fluency in Romanian and English are required, both written and spoken.

Where You'll Drive Impact

Site Identification, Feasibility & Selection

• 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.

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.
• 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.

Site Communication & Coordination

• 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.

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.
• 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 You Bring to the Team

• 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.

Preferred Qualifications

• Prior 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

• Site information and feasibility trackers are complete and kept up to date.
• Feasibility questionnaires and site documents are collected and reviewed on time.
• CROs and sponsors receive complete and organized site-level documentation.
• Sites in Romania and Moldova are supported during feasibility, SSV, SIV, activation, and early recruitment readiness.
• Open questions, missing documents, and delays are flagged early.
• Internal teams have accurate visibility into start-up status, risks, and next steps.
• The Romania and Moldova network is supported consistently, with the potential to expand support into additional Balkan countries as the network grows.

How We Work

• Collaborative and low-ego team environment
• High ownership and accountability culture
• Fast-paced and highly iterative growth environment
• Open communication and continuous learning mindset
• Mission-driven organization focused on improving patient outcomes
• Comfortable navigating evolving business priorities and opportunities