Clinical Research Associate (CRA)

Local responsibility for the delivery of clinical studies at assigned sites in Poland, acting as the main contact with study sites and ensuring compliance with ICH‑GCP and local regulations.

Responsibilities

• Identification, selection, initiation, monitoring, site data review, and closeout activities for assigned sites.
• Performing identification, selection, initiation, monitoring, site data review and closeout activities/visits (remote and onsite), including remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
• Driving site performance, proactively identifying and ensuring timely resolution of study‑related issues, and escalating as appropriate.
• Training, supporting, and advising investigators and site staff in study‑related matters, including Risk‑Based Quality Management (RBQM) principles.
• Developing recruitment plans with each site, managing and supporting enrollment to ensure sites and studies meet enrollment milestones, documenting recruitment barriers and implementing mitigation plans.
• Ensuring agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (action items aging, SDV metrics, data entry metrics, query aging, MV reports metrics, etc.).
• Preparing and finalizing monitoring visit reports in CTMS and providing timely feedback to the principal investigator, including follow‑up letters, within required timelines and in line with Alexion SOPs.
• Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH‑GCP, Alexion SOPs and local requirements, supporting/participating in regular QC checks of the eTMF.
• In some countries, as required, CRAs are accountable for study start‑up and regulatory maintenance, collecting, preparing, reviewing and tracking documents for the application process; submitting proper application/documents to EC/IRB and to regulatory authorities for start‑up and for the duration of the study.
• Contributing to the nomination and selection of potential investigators and assisting with feasibility activities.
• Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP) and other internal stakeholders, as needed.
• Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH‑GCP compliance issues to the global study team, local study team, country operations line management and/or quality group representatives as required.
• Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with other local team members Been

Required Qualifications

• Minimum 1 year of CRA monitoring experience.
• Bachelor’s degree in a related discipline, preferably in life science, or equivalent qualification.
• Excellent knowledge of ICH‑GCP, basic knowledge of GMP/GDP.
• Excellent knowledge of relevant local regulations.
• Good medical knowledge and ability to learn relevant Alexion therapeutic areas.
• Good understanding of the drug development process.
• Excellent understanding of clinical study management including monitoring, study drug handling and data management.
• Excellent attention to detail.
• Excellent written and verbal communication skills.
• Excellent collaboration and interpersonal skills.
• Good negotiation skills.
• Demonstrated flexibility in schedule and willingness to travel (travel may be as high as 70% during busy periods).
• Valid driving license.
• Solid knowledge of clinical development processes with strong emphasis on monitoring.
• The duties of this role are generally conducted in an office environment. As is typical of Pesquisa. An office-based role, employees must be able, with or without an accommodation, to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non‑linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Preferred Qualifications

• Ability to work in an environment of remote collaborators and in a matrix reporting structure.
• Ability to manage change with a positive approach for self, team, and the business nič.
• Ability to look for andklan.appspot.com through independent efficient and processes of delivering quality clinical trials with reduced budget and in less time.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
• Proactive and assertive when communicating with internal stakeholders and sites.
• Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e‑enabled environment.
• Team oriented and flexible; ability to mapas respond quickly to shifting demands and opportunities.
• Experience in all study phases and in rare medical conditions preferred.

Location

Central Poland.

Seniority level

Entry level.

Employment type

Full‑time.

Job function

Research, Analyst, and Information Technology.

Posting Information

Date Posted: 09‑sty‑2026 | Closing Date: 23‑sty‑2026.

Equal Opportunity Employer

Alexion is proud to be an Equal Employment Opportunity and affirmative action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race открыть color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E‑Verify.