Site Start-Up Associate II – Regulatory Submissions

Premier Research International; Poland; 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 our Clinical Monitoring, Site Management and SSU team. You will drive regulatory submissions and country-level site start-up activities to enable timely trials.

You will oversee EC/IRB and local approvals, negotiate budgets with sites, and ensure regulatory compliance. This role emphasizes collaboration across teams to deliver medical innovations that improve patient outcomes.

Qualifications

• Undergraduate degree in a clinical, science, or health-related field.
• 5+ years of related clinical trials experience, including at least 3 years submitting clinical trial applications via CTIS.
• Experience with interventional IMP studies and other study types (non-interventional, medical device, GMO) is advantageous.
• Experience in contract and budget negotiation with sites.
• Familiarity with FDA/EU regulations, ISO14155, and relevant local regulations.

Responsibilities

• Forecast submission/approval timelines and ensure adherence.
• Prepare and submit EC/IRB, RA, and local approvals; assist with issue resolution at country level.
• Prepare ongoing submissions, amendments, and safety reports per local regulations.
• Review documents for sponsor and investigator requirements; ensure ICH/GCP compliance.
• Lead site identification/feasibility process at country level.
• Prepare Investigational Product checklist per country regulations.
• Ensure Trial Master File completeness and perform QC reviews when acting as document owner.

Skills

Clinical trials experience

CTIS submissions

Contract and budget negotiation

Regulatory knowledge

Education

Bachelor's degree in clinical/science/health

Job description

Premier Research is seeking a Site Start Up Associate I/II to join our Clinical Monitoring, Site Management and SSU team. You will drive regulatory submissions and country-level site start-up activities to enable timely trials.

You will oversee EC/IRB and local approvals, negotiate budgets with sites, and ensure regulatory compliance. This role emphasizes collaboration across teams to deliver medical innovations that improve patient outcomes.