Site Start up Associate I / II

Premier Research; 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 the Clinical Monitoring, Site Management and SSU team in Poland. The role supports biotech, medtech, and pharma firms by preparing regulatory submissions and coordinating site contracts to enable timely trials.

The ideal candidate has substantial start-up experience, strong knowledge of CTIS submissions, and familiarity with FDA/EU guidelines.

Qualifications

• Undergraduate degree in clinical, science, or health field.
• 5+ years of related clinical trials experience, including 3+ years in CTIS submissions.
• Experience in contract and budget negotiation with sites.
• Knowledge of FDA/EU regulations and ISO14155.

Responsibilities

• Forecast submission/approval timelines and ensure adherence.
• Prepare and submit EC/IRB, Local EC, RA, and other local submissions; assist with issue resolution.
• Prepare ongoing submissions, amendments, and notifications including safety reporting.
• Collect and review essential documents to ensure sponsor and investigator compliance with local regulations.
• Negotiate site contracts and budgets; coordinate with Contracts Lead until resolution.
• Conduct country-level site identification/feasibility assessments.
• Prepare IP checklist according to country regulations.
• Ensure TMF documents are accurate and QC’d for sites acting as document owner.

Skills

Site start up

Clinical trials

Regulatory submissions

Budget negotiation

Education

Undergraduate degree in clinical/health field

Job description

Premier Research is looking for a Site Start up Associate I / II to join our Clinical Monitoring, Site Management and SSU team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• Your ideas influence the way we work, and your voice matters here.
• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing

• Forecast submission/approval timelines and ensures they are adhered to.
• Prepare and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Assists with EC/IRB or CA issue resolution at the country level.
• Prepare ongoing submissions, amendments, and periodic notifications (including safety reporting) required by central and local EC and RA, and other local regulatory authorities as needed within the country, as required by local rules.
• Perform essential document collection and review, ensuring that sponsor and investigator requirements are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
• Local Investigator Contract and Budget Negotiator - produces site-specific contracts from country template. Submit proposed contract and budget to the site for review. Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.
• Conduct the site identification/feasibility process on a country level.
• Prepare Investigational Product (IP) checklist according to country regulations.
• Ensure accuracy and completeness of Trial Master File documents submitted throughout the study and performs a QC review of files for which Start-up Associate is acting as document owner.

What We Are Looking For

• Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional.
• 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.
• Submissions will be mainly interventional IMP studies. Experience working on different study types/phases such as non-interventional studies, medical device studies, GMO studies, and observational studies etc. an advantage.
• Experience in contract and budget negotiation with sites
• Working knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations, drug / device development and clinical monitoring procedures.

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The minimum annualized starting base pay for a level I position is 113,000 PLN and for level II position it is 143,000 PLN. The actual salary will be influenced based on a variety of factors such as qualifications, skills, competencies, and proficiency for the role. We also offer comprehensive benefits packages, which may include health insurance, life insurance, retirement plan, paid time off, and an Employee Assistance Program.