O SEU PRÓXIMO CAPÍTULO
Assistant CRA
Sobre a vaga
• Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead
• Support site preparedness and provide logistical support to the monitoring process
• Assist with site management and remote monitoring activities in accordance with SOPs and regulatory guidelines
• Complete study and site management activities defined in the task matrix
• Complete and document study-specific training and training on study-specific systems
• Support pre-study assessments and waivers
• Customize site ICFs with site contact details as needed
• Perform remote review of EMR/EHR checklists
• Verify document collection, RCR submission status, site EDL, and site information
• Review patient-facing materials and translations
• Support vendor qualification, system access, site staff training, and vendor trackers
• Coordinate logistics for IM attendance and study/site supply management
• Collect, review, and update essential documents in systems
• Follow up on missing vendor data including ECGs, lab samples, and e-diaries
• Support remote review of centralized monitoring tools
• Coordinate site payment processes, system updates, reconciliations, and invoice follow-up
• Perform reconciliation tasks involving CRF and query status, deviations, SAEs, and safety reports
• Verify document collection status and drive action for missing, incomplete, expired, or outstanding documents
• Perform other assigned site management tasks as directed by the CRA and task matrix
• Complete administrative tasks including expense reports and timesheets
• Bachelor's degree in a life science discipline
• 1–2 years of previous experience providing the knowledge, skills, and abilities to perform the job
• Equivalency may be considered through a combination of appropriate education, training, and/or directly related experience
• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain 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
• Proven ability to handle multiple tasks efficiently and effectively
• Flexibility and adaptability
• Ability to work in a team or independently
• Well-developed critical thinking, root cause analysis, and problem-solving skills
• Proficient computer skills and good knowledge of MS Office
• Ability to learn and use appropriate software
• Ability to extract pertinent information from study documents, electronic study data systems, CTMS, and dashboards
• Excellent English and Turkish language and grammar skills
• Competitive salary
• Extensive benefits package focused on employee health and well-being
• Flexible working culture
• Work-life balance
• Collaborative environment
• Professional development and knowledge sharing
• Global team environment with a local feel