Site Start-Up & Regulatory Specialist

61 Premier Research Poland Sp. z.o.o; Poland; On-site; PLN 113,000 - 143,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Retirement plan

Paid time off

Employee Assistance Program

Job summary

Premier Research Poland is seeking a Site Start Up Associate I/II to support clinical monitoring, site management and SSU activities in Poland. You will manage regulatory submissions, site contracts, and feasibility assessments for various trial types, ensuring compliance with local and international guidelines.

The role requires substantial experience in CTIS submissions, regulatory submissions, and contract/budget negotiations with sites, contributing to timely study start-up and high-quality

Qualifications

• Undergraduate degree or international equivalent in a clinical, science, or health-related field.
• Proven experience as a Site Start Up Associate I and/or 5+ years of related clinical trials experience, including at least 3 years of experience in the submission of clinical trial applications via CTIS.
• Experience with interventional IMP studies and a range of study types is advantageous.

Responsibilities

• Forecast submission/approval timelines and ensure adherence.
• Prepare and submit Central EC/IRB Applications, Local EC Applications, RA Applications, and other required submissions.
• Assist with EC/IRB or CA issue resolution at country level.
• Prepare ongoing submissions, amendments, and periodic notifications including safety reporting.
• Collect and review essential documents to meet sponsor and investigator requirements and local regulations.
• Prepare site contracts and budgets; negotiate with sites and Sponsors until resolution.
• Conduct country-level site identification/feasibility processes.
• Assemble Investigational Product (IP) checklists per country regulations.
• Ensure Trial Master File documents are accurate and QC’d by the Start-Up Associate.

Skills

Clinical trials experience

CTIS submissions

Education

Undergraduate degree / international equivalent in clinical science or health

Job description

Premier Research Poland is seeking a Site Start Up Associate I/II to support clinical monitoring, site management and SSU activities in Poland. You will manage regulatory submissions, site contracts, and feasibility assessments for various trial types, ensuring compliance with local and international guidelines.

The role requires substantial experience in CTIS submissions, regulatory submissions, and contract/budget negotiations with sites, contributing to timely study start-up and high-quality