Assistant CRA

• 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 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
• Provide in-house support during pre-study assessments and waivers
• Customize Site ICF with site contact details as needed
• Perform remote EMR/EHR checklist reviews
• Verify document collection and RCR submission status; update site EDL and site information
• Review patient-facing materials and translations
• Support vendor qualification processes and site staff system access
• Follow up on site staff training
• Coordinate logistics for IM attendance and maintain vendor trackers
• Coordinate study/site supply management
• Support Essential Document collection, review and updating
• 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 for CRFs, queries, deviations, SAEs and safety reports
• Verify document collection status and drive action on missing or incomplete documentation
• Perform other assigned site management tasks and FSP role profiles as directed
• Complete administrative tasks including expense reports and timesheets

• Bachelor's degree in a life science discipline or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification
• Previous experience comparable to 0 to 2 years
• An equivalency combining appropriate education, training and/or directly related experience may be considered sufficient
• Basic medical/therapeutic area knowledge and understanding of medical terminology
• 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
• 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 language and grammar skills

• Fully remote work arrangement
• Standard Monday-Friday work schedule
• Office or home office environment
• Occasional travel to clinics/hospitals may be required