Assistant CRA

• Perform remote activities on assigned clinical research 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 tasks 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 learn study-specific systems
• Support pre-study assessments, waivers and site ICF customization
• Perform remote EMR/EHR checklist review and support collection activities
• Verify document collection, RCR submission status and site information
• Review patient-facing materials and translations
• Support vendor qualification, system access, staff training and IM attendance logistics
• Maintain vendor trackers and coordinate study/site supply management
• Support essential document collection, review and updating in systems
• Follow up on missing vendor data including ECGs, lab samples and e-diaries
• Support remote review of centralized monitoring tools
• Support 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 or expired documents
• Perform other assigned site management tasks as directed by the CRA
• Complete administrative tasks including expense reports and timesheets promptly

• Bachelor's degree in a life science discipline
• Previous experience comparable to 1–2 years
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• 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 and leverage modern technology
• Ability to extract pertinent information from study documents, electronic study data systems, CTMS and dashboards
• Excellent English and Turkish language and grammar skills
• Willingness/ability to perform remote activities and limited site contact activities as assigned

• Competitive salary
• Extensive benefits package based around the health and well-being of employees
• Flexible working culture
• Work-life balance
• Collaborative environment
• Opportunities to share expertise and collaborate with colleagues
• Diverse experiences, backgrounds and perspectives valued