Site Start-Up Specialist I/II — Drive Life-Saving Trials

Premier Research; Polska; On-site; PLN 113,000 - 143,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Employee Assistance Program

Job summary

Premier Research is seeking a Site Start up Associate I/II to join the Clinical Monitoring, Site Management and SSU team in Poland. The role involves regulatory submissions, country-level site identification, budget negotiation, and ensuring compliance with ICH/GCP guidelines.

You will prepare EC/IRB and local approvals, manage site contracts, and coordinate essential document collection and QC across the Trial Master File. Prior CTIS submission experience is required.

Qualifications

• Undergraduate degree in a clinical, science, or health related field from an accredited institution.
• Experience as Site Start Up Associate I and/or 5+ years of related clinical trials experience, including CTIS submissions.
• Experience in contract and budget negotiation with sites.
• Familiarity with FDA/EU directives and ISO14155 regulations.

Responsibilities

• Forecast submission/approval timelines and ensure adherence.
• Prepare and submit EC/IRB, RA, and local approvals, plus issue resolution.
• Prepare ongoing submissions, amendments, and periodic safety notifications.
• Perform document collection/review to meet sponsor and investigator requirements.
• Negotiate site contracts and budgets with the site and Contracts Lead.
• Conduct country-level site identification/feasibility.
• Prepare Investigational Product checklists per regulations.
• QC site Master File submissions and act as document owner.

Skills

Regulatory submissions

Contract & budget negotiations

Site start-up processes

Documentation review

CTIS submissions

Regulatory knowledge (FDA/EU/ISO)

Communication & cross-functional work

Education

Undergraduate degree in clinical/science/health

Job description

Premier Research is seeking a Site Start up Associate I/II to join the Clinical Monitoring, Site Management and SSU team in Poland. The role involves regulatory submissions, country-level site identification, budget negotiation, and ensuring compliance with ICH/GCP guidelines.

You will prepare EC/IRB and local approvals, manage site contracts, and coordinate essential document collection and QC across the Trial Master File. Prior CTIS submission experience is required.