Assistant CRA – FSO

• Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead
• Support site preparedness and the clinical trial monitoring process
• Assist with site management and remote monitoring in accordance with SOPs and regulatory guidelines
• Perform limited site contact activities during study start-up, site management, recruitment and close-out phases
• Complete study and site management activities defined in the task matrix
• Complete and document study-specific training and orient on study-specific systems
• Provide in-house support during pre-study assessments and assessment waivers
• Customize site informed consent forms with site contact details as needed
• Perform remote review of EMR/EHR checklists
• Verify document collection, RCR submission status and site information
• Review patient-facing materials and translations
• Support vendor qualification, system access, site staff training and vendor tracker maintenance
• Coordinate logistics for IM attendance and study/site supply management
• Support essential document collection, review and system updates
• Follow up on missing vendor data, including ECGs, lab samples and e-diaries
• Support ongoing remote review of centralized monitoring tools
• Support site payment processes, system updates, reconciliations and invoice follow-up
• Perform trial 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 and client-requested FSP role profiles
• Complete administrative tasks including expense reports and timesheets

• Bachelor's degree in a life science discipline or related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification
• Previous experience comparable to 0 to 2 years
• Equivalent combination of appropriate education, training and/or directly related experience may be considered
• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Working knowledge of ICH GCP, applicable regulations and company procedural documents, or ability to attain and maintain it
• 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 language and grammar skills

• Fully remote work arrangement
• Occasional travel to clinics/hospitals may be required
• Opportunity to work with a global team
• Potential CRA career-track promotional opportunities