Assistant CRA

• Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead
• Support site preparedness and the 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
• Orient and train on study-specific systems
• Provide in-house support during pre-study assessments and pre-study assessment waivers
• Customize site ICFs with site contact details as needed
• Perform remote review of EMR/EHR checklists and support applicable assessments
• Verify document collection and RCR submission status; update site EDL and verify site information
• Review patient-facing materials and translations
• Support site staff with vendor-related qualification processes
• Support system access requests, grants, and revocations for site staff
• Follow up on site staff training
• Coordinate logistics for IM attendance
• Maintain vendor trackers
• Coordinate study/site supply management
• Support Essential Document collection, review, and updating in systems
• Follow up on missing vendor data such as 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 on 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
• Serve as the primary point of contact for sites on legacy studies

• Bachelor's degree in a life science discipline or related field, or Registered Nursing certification or equivalent 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
• 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
• Ability to handle multiple tasks efficiently and effectively
• Flexibility and adaptability
• Ability to work independently or in a team
• 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 language and grammar skills

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Occasional travel to clinics/hospitals may be required
• Opportunity to work with a global team supporting pharmaceutical and biotechnology clinical trials
• Potential promotional opportunities in the CRA career track