Site Start-Up & Feasibility Specialist

This is a fully remote position, open to applicants in Romania.

📋 Description

• Assist in the gathering and upkeep of information regarding qualified IBD clinical trial sites in Romania and Moldova.

• Aid in ensuring that site capability information remains current, which includes investigator experience, patient access, and fundamental operational readiness.

• Contribute to feasibility activities by coordinating CDA execution, collecting site input, and providing assistance with feasibility questionnaires.

• Evaluate feasibility responses for thoroughness and consistency before they are reviewed internally or by CRO/sponsors.

• Prepare feasibility information for CROs, sponsors, and internal stakeholders.

• Monitor feasibility status, outstanding questions, and subsequent steps.

• Assist in site start-up activities from feasibility through regulatory and contractual readiness, SSV/SIV preparation, activation, and initial recruitment readiness.

• Gather, organize, and perform quality checks on site-level documents using CRO and sponsor templates.

• Review documents for missing items, expired credentials, formatting issues, and basic inconsistencies prior to submission.

• Aid in preparing sites for selection and initiation visits by communicating document requirements, timelines, and expectations.

• Attend site visits when necessary and appropriate.

• Maintain start-up checklists and trackers under the supervision of internal team members.

• Identify blockers or delays promptly and escalate them to the relevant internal contact.

• Assist in activation planning and help sites prepare for patient screening activities following regulatory approval.

• Act as the primary operational contact for sites in Romania and Moldova during feasibility and study start-up phases.

• Coordinate site inquiries and direct them to the correct internal, CRO, or sponsor contacts as required.

• Communicate effectively with PIs, study coordinators, site staff, CRO start-up teams, and internal stakeholders.

• Educate sites about Iterative Health services, tools, checklists, and workflows.

• Maintain clear, professional, and timely communication with sites and study partners.

• Keep accurate updates within Salesforce, Asana, study trackers, and other relevant systems.

• Track action items, document statuses, owners, due dates, and follow-up tasks.

• Support basic reporting on feasibility turnaround, document completion, SSV/SIV readiness, activation timelines, and site responsiveness.

• Identify recurring document or start-up issues and communicate them to the internal team.

• Adhere to established processes and offer suggestions for improvement when suitable.

• Perform related duties as assigned.

⛳️ Requirements

• At least 3 years of experience in clinical research, ideally within a CRO, site start-up, feasibility, site management, or clinical research coordination role.

• Experience in supporting pharma-sponsored clinical trials, preferably Phase 2–4 studies.

• Familiarity with site feasibility, study start-up documentation, site communication, or regulatory/start-up coordination.

• Required experience in IBD clinical trials.

• Basic knowledge 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 accurately maintain trackers, timelines, action logs, and document status updates.

• Strong attention to detail and consistent follow-up skills.

• Ability to identify risks, delays, or missing information and escalate them appropriately.

• Fluency in both Romanian and English is mandatory, in written and spoken forms.

• A 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 necessary.

• Potential travel to additional Balkan countries may be required if the regional network expands.

🏝️ Benefits

• Private medical coverage

• Life insurance

• Retirement benefits

• Paid time off