[Hiring] Clinical Research Associate II/III @Optimapharm .

Role Description

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.

Qualifications

• 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

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

Benefits

• 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