Senior Site Start-Up & Feasibility Specialist

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. 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. Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.

As a Senior Site Start -Up & feasibility Specialist at Iterative Health you will own and shape a regional start-up function from the ground up. As Iterative Health scales its ex-US site network across Central/Eastern Europe and Georgia, this role sits at the center of that growth - building the systems, playbooks, and site relationships that will define how we activate studies across more than 20 sites and counting. Reporting to the Director of Clinical Research Operations for CEE, you won't just be executing a process; you'll be creating a repeatable, scalable model that accelerates patient access to novel therapies across the region. The ideal candidate is a disciplined, operationally sharp professional who thrives in complex, multi-country environments and is energized by leaving things better than they found them.

Location: Remote, Poland
Employment Type: Full-Time EOR
Compensation: PLN 240,000 - PLN 300,000 gross annual base salary, 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.

Where You'll Drive Impact

Site Identification, Feasibility & Selection

• Maintain a curated view of pre-qualified sites with GI expertise, capabilities, track record, and validated patient access across the CEE and Georgia region.
• Map protocol requirements to specific sites and quickly confirm operational fit.
• Coordinate CDA execution, pre-fill and complete feasibility questionnaires with PIs and site teams, validate responses against site-level reality, and deliver consolidated, CRO-ready feasibility input.
• Drive feasibility quality and speed to improve turnaround times and accuracy across the network.
• Orchestrate day-to-day execution across sites from CDA/feasibility through CTR readiness, SSV/SIV, activation, and early recruitment readiness - keeping sites, CROs, sponsors, and internal teams aligned.
• Collect, pre-fill, and quality-check site-level documents against CRO and sponsor templates; screen for missing items, expired credentials, and formatting gaps prior to handoff.
• Prepare sites for selection visits (SSVs) and initiation visits (SIVs), ensuring documentation, role expectations, and operational readiness are clearly understood; attend site visits in person when valuable.
• Run site-side readiness activities in parallel with regulatory review, maintain practical pre-activation checklists, escalate blockers early, and support activation and first patient screened within 14 days post-CTR approval wherever feasible.
• Serve as the first-line operational partner for sites - triaging questions, unblocking issues quickly, and escalating clearly when sponsor, CRO, or leadership alignment is required.
• Work directly with PIs, senior site staff, CRO start-up and feasibility teams, and internal cross-functional stakeholders to drive alignment and execution.
• Maintain accurate updates in Salesforce, Asana, and study trackers, including action logs, decision logs, risk items, owners, and due dates.
• Train site teams on Iterative Health services, tools, checklists, and workflows.
• Convert recurring start-up issues into reusable templates, trackers, and lightweight playbooks across the European network.
• Monitor cycle times, feasibility turnaround, SIV-to-activation timelines, document query rates, site responsiveness, and screen/enroll trends.
• Use data to proactively identify bottlenecks, simplify processes, and drive measurable improvements in activation timelines across the network.
• Performs related duties as requested

What You Bring to the Team

• 5+ years of experience in clinical operations, site start-up, feasibility, site management, or senior clinical research coordination, preferably in Phase 2 - 4 pharma-sponsored trials.
• Bachelor's degree or higher in life sciences, healthcare, pharmacy, nursing, biotechnology, public health, or a related field; advanced degree and/or clinical research certification preferred.
• Hands-on CRO and/or sponsor-facing experience in site identification, selection, feasibility, and study start-up activities.
• IBD clinical trial experience.
• Strong understanding of ICH-GCP, site operations, regulatory and start-up documentation, SSV/SIV preparation, and early recruitment readiness.
• Experience coordinating multiple sites and countries, ideally across Central/Eastern Europe, Georgia, or similarly complex regional environments.
• Proven ability to manage trackers, timelines, action logs, document QC, and stakeholder communication with disciplined execution.
• Strong ability to identify operational risks early, escalate clearly, and drive issues to resolution.
• Clear written and verbal communication skills in English; regional language skills are a plus.
• Willingness to travel approximately 20% across Central/Eastern Europe and Georgia for site visits.

Preferred Qualifications

• Prior experience supporting or coordinating site networks.
• Experience with Salesforce, Asana, CTMS/eTMF platforms, Excel/Google Sheets, and Microsoft/Google productivity tools; EDC familiarity is a plus.
• Experience supporting clinical trials in MASLD, obesity, and/or cardiology.
• Experience creating SOPs, playbooks, site-facing templates, trackers, or training materials.
• Experience working in fast-growing, remote-first, international teams.

What Success Looks Like

• Feasibility responses are faster, more accurate, and better aligned with real site capabilities.
• Sites are well-prepared for SSVs, SIVs, activation, and early recruitment.
• CROs and sponsors receive clean, complete, and timely site-level documentation.
• Start-up blockers are identified early and escalated before they impact activation timelines.
• Site activation and first patient screened timelines improve measurably across the CEE network.
• Iterative Health has a repeatable, scalable start-up and feasibility model across Central/Eastern Europe and Georgia.

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

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.