Clinical Research Associate

Warman O'Brien; Poland; On-site; PLN 120,000 - 180,000; Full time

Job summary

Warman O'Brien is seeking experienced Senior Clinical Research Associates (CRA) & CRA II for Poland, within a dedicated sponsor model with a leading global pharmaceutical company.

You will monitor sites across Poland, ensuring high quality, compliance and patient safety, and collaborate with investigators, study teams and cross-functional colleagues to deliver studies on time.

Qualifications

• Independent clinical monitoring experience at Senior CRA/CRA II level or equivalent.
• Strong knowledge of ICH-GCP and applicable regulations.
• Site management and relationship-building skills.
• Fluency in Polish and English.
• Willingness to travel to clinical trial sites as required.

Responsibilities

• Conduct site qualification, initiation, routine monitoring and close-out visits.
• Manage assigned clinical trial sites and maintain strong relationships with investigators and site teams.
• Ensure studies are conducted per protocol, ICH-GCP, and applicable regulations.
• Monitor site performance, recruitment, data quality and protocol compliance.
• Identify potential site or study issues and work with stakeholders to resolve them.
• Ensure monitoring reports and documentation are completed accurately and timely.
• Support maintenance and quality of essential study documentation.
• Collaborate with local and international clinical operations and cross-functional teams.
• Maintain oversight of sites, priorities and study timelines.

Skills

Independent monitoring experience

ICH-GCP knowledge

Site management

Polish and English fluency

Travel willingness

Job description

We are currently looking for experienced Senior Clinical Research Associates & Clinical Research Associates II (CRA II) based in Poland for an opportunity within a dedicated sponsor model, supporting the clinical development activities of a leading global pharmaceutical company.

This is an excellent opportunity for an experienced CRA looking to work closely with one sponsor, gain deeper exposure to its studies, systems and processes, and become an integrated part of the wider clinical operations team.

The Role

As a CRA, you will take responsibility for the monitoring and management of clinical trial sites across Poland, helping to ensure studies are delivered to the highest standards of quality, compliance and patient safety.

You will manage your assigned sites throughout the study lifecycle, working closely with investigators, site staff and study teams to support successful study delivery.

Key Responsibilities

• Conduct site qualification, initiation, routine monitoring and close-out visits.
• Manage assigned clinical trial sites and maintain strong relationships with investigators and site teams.
• Ensure studies are conducted in accordance with the protocol, ICH-GCP, applicable regulations and relevant procedures.
• Monitor site performance, recruitment, data quality and protocol compliance.
• Identify potential site or study issues and work proactively with relevant stakeholders to resolve them.
• Ensure monitoring reports and associated documentation are completed accurately and within required timelines.
• Support the maintenance and quality of essential study documentation.
• Collaborate with local and international clinical operations and cross-functional study teams.
• Maintain effective oversight of assigned sites, priorities and study timelines.

About You

To be successful in this position, you will ideally have:

• Previous independent clinical monitoring experience, at Senior CRA/CRA II level or equivalent.
• Experience managing clinical trial sites throughout different stages of the study lifecycle.
• Strong knowledge of ICH-GCP and applicable clinical research regulations.
• Strong site management and relationship-building skills.
• The ability to work independently and effectively manage multiple priorities.
• Excellent communication and organisational skills.
• Fluency in Polish and English.
• Availability to travel to clinical trial sites as required.

The Opportunity

The dedicated sponsor model provides the opportunity to become closely aligned with one global pharmaceutical organisation and its clinical development portfolio, while working within an established clinical research environment.

For an experienced CRA looking for greater sponsor integration, long-term development opportunities and the chance to build deeper knowledge of a single sponsor's studies and processes, this could be an excellent next career move.