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
• 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 learn 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 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 vendor-related qualification processes for site staff
• 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, 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, including 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-specific FSP role profiles
• Complete administrative tasks such as expense reports and timesheets

• Bachelor's degree in a life science discipline, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0–2 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
• 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 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 leading pharmaceutical companies and biotech companies across global clinical trials