Clinical Research Associate II/III - Poland

Optimapharm; Kraków; On-site; PLN 110,000 - 160,000; Full time

Benefits offered by this job

Performance bonus

Flexible hours

Car allowance

Work from home allowance

Health insurance

Training program

Well-being initiatives

Employee engagement

Job summary

Optimapharm in Poland is seeking a Clinical Research Associate (CRA II-III) to join our growing global team. You will perform routine site visits, monitor trials, and manage site relationships to ensure compliance and quality data.

Ideal candidates have a university degree in life sciences, at least 2 years of independent monitoring experience, strong knowledge of ICH GCP, and fluent English and Polish. This role offers professional growth and integration into international projects.

Qualifications

• University degree in medical or life sciences is required.
• At least 2 years of independent clinical trial monitoring experience.
• High level of knowledge of ICH GCP guidelines and regulatory requirements.
• Fluent in Polish and English, both written and verbal.
• Computer proficiency is mandatory.

Responsibilities

• Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits.
• Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements.
• Independently perform CRF review; query generation and resolution against data review guidelines or data management systems.
• Identify and escalate potential risks and retraining opportunities for site personnel.
• Prepare CAPA plans for issues identified during monitoring activities and follow through until resolution.
• Prepare documents required for EC submissions and notifications, translate study-related documents where applicable, and other tasks as instructed by the supervisor.
• Independently negotiate study budgets with investigators/institutions and assist with site contracts as applicable.
• Administration of site payments in accordance with project instructions.

Skills

ICH GCP knowledge

Regulatory awareness

English fluency

Polish fluency

Independent monitoring

Education

University degree in medical or life sciences

Tools

Data management systems

Job description

Location: Poland

Who we are?

Optimapharm is a mid-sized, global Contract Research Organisation turning science into hope through agile, patient-focused clinical development.

At Optimapharm, you'll have the opportunity to work on diverse and meaningful projects that help bring innovative therapies to patients worldwide. As part of our international team, you'll collaborate with experts across multiple disciplines, gain exposure to a broad range of therapeutic areas, and contribute to research that makes a real difference.

With colleagues in 26 countries and operations in more than 40 countries, we combine global reach with the agility, collaboration, and supportive culture of a mid-sized organisation. Here, your expertise is valued, your growth is encouraged, and your work has a visible impact.

We’re looking for a Clinical Research Associate (CRA II - III, depending on experience) to join our team in Poland. Whether you’re building your expertise as a CRA I or ready to step into a higher CRA role, this is your chance to shape the future of clinical research - delivering excellence and meaningful impact for patients and families worldwide. This role sits within a defined CRA career path: CRA I → CRA II → CRA III → Senior CRA.

What do we offer?

• Working in a successful company that’s growing and developing every day
• Being part of a clinical research team that transforms science into hope for patients
• International projects and professional growth
• Working with a highly experienced team of clinical research professionals
• Performance bonus
• Flexible work hours
• Car allowance
• Work from home allowance
• Additional health insurance
• Employee engagement programs
• Well-being initiatives
• Training and development program

Who are we looking for?

Qualifications and Experience

• University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
• At least 2 years of independent clinical trial monitoring experience (nephrology/urology, infectious diseases experience is a plus)
• High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
• Fluent in local language and English, both written and verbal
• Computer proficiency is mandatory
• Ability to read, analyze, and interpret common scientific and technical journals
• Excellent verbal and written communication skills
• Very good interpersonal and negotiation skills
• Ability to work independently, pro-active
• Affinity to work effectively and efficiently in a matrix environment
• A current, valid driver’s license

Your responsibilities

• Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits
• Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements
• Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable
• Identifying and escalating potential risks and identifying retraining opportunities for site personnel
• Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution
• Preparation of documents required for EC submissions and notifications, translation of study-related documents (where applicable), and other tasks as instructed by the supervisor
• Independently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable
• Administration of site payments in accordance with relevant project instructions

Compensation is competitive and final offers will reflect each candidate’s experience, skills, and qualifications.