Assistant CRA
HybridBudapest, Budapest, Hungary
Job Summary
Complete study and site management activities per task matrix, including pre-study assessments, document collection verification, and remote review of EMR/EHR checklists. Support site staff with vendor qualification, system access management, and supply coordination while tracking missing data like ECGs and lab samples. Perform administrative duties such as expense reporting, eTMF reviews, and investigator file documentation to ensure compliance with SOPs and regulatory guidelines. Coordinate logistics for IM attendance and site payments, maintaining vendor trackers and essential document status throughout the study period.
Required Qualifications
- Bachelor's degree in a life science discipline or related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years)
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents
- Effective oral and written communication skills
- Excellent interpersonal and customer service skills
- Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Proven flexibility and adaptability
- Ability to work in a team or independently, as required
- Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
- Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable
- Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
- Excellent English language and grammar skills
- Willingness and motivation to develop into an on-site Clinical Research Associate (CRA) role as part of a long-term career path
- occasional travel to clinics/hospitals may be required
- The Assistant CRA role does not involve regular travel
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