Senior Clinical Research Associate -Oncology/CNS (Poland)

Worldwide Clinical Trials Limited spółka z ograniczoną odpowiedzialnością; Poland; Remote; PLN 90,000 - 130,000; Full time

Job summary

Worldwide Clinical Trials Limited spółka z ograniczoną odpowiedzialnością is seeking a Senior Clinical Research Associate for a home-based role in Poland. You will lead site qualification, initiation, monitoring, and close-out activities while ensuring GCP, regulatory requirements, and SOPs are followed.

You will monitor patient safety, build strong relationships with investigators, and mentor junior CRAs on global studies when required.

Qualifications

• MD or Pharmacy degree with CRA experience
• Four-year degree in medical/biological/health/pharmacy with CRA experience
• Two-year college curriculum with CRA experience, preferably in nursing/life sciences
• Oncology experience required; ability to lead CRA activities when appropriate

Responsibilities

• Lead site qualification, initiation, monitoring and close-out in line with protocols and SOPs.
• Monitor study quality and patient safety through source data verification, consent reviews, CRF and data query resolution.
• Build relationships with investigators and site teams, providing protocol guidance and training.
• Coordinate Lead CRA activities on global studies, reviewing visit reports and mentoring other CRAs.
• Develop monitoring plans and study tools to support effective study delivery.

Skills

Communication skills

Interpersonal skills

Planning

Organization

Time management

Initiative

Problem-solving

Polish language

English language

Education

MD or Pharmacy degree

Bachelor/4-year degree in life sciences

2-year college in nursing or life sciences

Tools

Microsoft Office

IxRS

EDC systems

Job description

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. Make an Impact as a Senior Clinical Research Associate at Worldwide

As a Senior Clinical Research Associate, you’ll play a key role in protecting patient safety and ensuring the quality and integrity of clinical trial data. From site qualification and initiation through ongoing monitoring and close-out, you’ll help sites deliver studies in line with protocols, GCP, regulatory requirements, and SOPs. You’ll take ownership of site relationships and monitoring activities while working closely with Project Management, investigators, site staff, and global study teams. Depending on the study, you may also step into a Lead CRA role, coordinating and mentoring other CRAs and contributing your expertise to monitoring plans, training, study tools, and processes. This is an opportunity to bring significant CRA experience to complex clinical studies while helping study teams and sites maintain high standards of quality, compliance, and patient safety.

Where You'll Work

This is a home-based Clinical Research Associate role supporting sites across Poland. Candidates must reside within the territory to effectively support site visits and study activities. You will collaborate with sites, sponsors, and global study teams while traveling to investigative sites approximately 8-10 days per month. To best support our sites, we’re seeking candidates who are based in Poland. Travel will primarily be regional, with occasional travel to support sites in other locations as needed.

What You’ll Do

Lead site qualification, initiation, interim monitoring, management, and close-out activities in line with study protocols, GCP, regulatory requirements, and SOPs. Monitor study quality and patient safety through source document verification, informed consent and safety information review, CRF review, and support with data query resolution. Build effective relationships with investigators and site teams, providing ongoing communication, protocol guidance, training, and support throughout the study lifecycle. Ensure essential regulatory, ethics, Investigator Site File, TMF, and investigational product documentation and accountability requirements are appropriately maintained. Partner with Project Management and study teams to evaluate deliverables, study milestones, site performance, and monitoring requirements. Coordinate CRAs as a Lead CRA on global studies when required, including reviewing visit reports and providing mentoring, guidance, and accompanied site visits. Develop monitoring plans, study-specific tools, templates, and training materials as requested to support effective study delivery. Contribute clinical monitoring expertise to study team and investigator meetings, bid defenses, protocols, CRFs, and process initiatives.

What You’ll Bring

Education and experience: An MD or Pharmacy degree with at least 3 years of CRA experience; a four-year degree in medical, biological, physical, health, pharmacy, or a related science with at least 5 years of CRA experience; or a two-year college curriculum or equivalent education/training, preferably in nursing or life sciences, with at least 7 years of CRA experience. Experience in full-service monitoring prefered. Strong clinical research expertise, including a thorough understanding of GCP, ICH Guidelines, FDA and/or EU regulations and directives, local regulatory requirements, and SOPs. Experience in Oncology required (CNS is an advantage), with the depth of knowledge needed to operate as a Lead CRA when appropriate. Excellent communication, interpersonal, planning, organization, time-management, initiative, and problem-solving skills, with the ability to lead and motivate others when applicable. Proficiency with Microsoft Office, IxRS, and EDC systems. Fluency in Polish and proficiency in spoken and written English. A valid current passport and driving license, with willingness to travel as required.

Discover the Difference We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.

This is who we are. We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.