CRA II: Site Monitoring & Trial Partnerships

Novotech; Warszawa; On-site; PLN 120,000 - 160,000; Full time

Job summary

Novotech in Warsaw, Poland is seeking a Clinical Research Associate (CRA) to protect trial participants and verify data against source documents. The CRA is the primary contact between Investigational Sites, Novotech, and Sponsors to ensure trials are conducted per ICH GCP and local/global regulations.

They will build strong site relationships, support regulatory submissions, monitor across study phases, and ensure data integrity while complying with SOPs and timelines.

Qualifications

• Must hold a degree in life sciences or clinical field.
• Strong time management and organizational skills.
• Ability to work well in a team and handle multiple tasks.
• Experience in clinical research or pharma is advantageous.

Responsibilities

• Learn company policies and CRA training programs.
• Manage quality study deliverables at country/site level.
• Build relationships with investigators and trial staff.
• Ensure site recruitment and engagement per protocol.
• Prepare essential documents and assist with regulatory submissions.
• Monitor sites in accordance with ICH GCP and CMP.
• Maintain TMF and audit readiness.
• Provide site updates and escalate issues as needed.

Skills

Time management

Teamwork

Computer literacy

Attention to detail

ICH GCP knowledge

Education

Bachelor's in life sciences

Job description

Novotech in Warsaw, Poland is seeking a Clinical Research Associate (CRA) to protect trial participants and verify data against source documents. The CRA is the primary contact between Investigational Sites, Novotech, and Sponsors to ensure trials are conducted per ICH GCP and local/global regulations.

They will build strong site relationships, support regulatory submissions, monitor across study phases, and ensure data integrity while complying with SOPs and timelines.