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 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 for pre-study assessments and waivers
• Customize Site ICFs with site contact details as needed
• Perform remote EMR/EHR checklist reviews and support assessments
• Verify document collection and RCR submission status; update site EDL and site information
• Review patient-facing materials and translations
• Support vendor qualification, system access, site staff training, IM attendance, vendor trackers, and study/site supplies
• 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 reconciliation tasks for CRFs, queries, 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 such as expense reports and timesheets

• 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
• 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
• Ability to handle multiple tasks efficiently and effectively
• Flexibility and adaptability
• Ability to work independently or in a team
• 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 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
• Standard Monday–Friday work schedule
• Home office environment
• Occasional travel to clinics/hospitals may be required
• Opportunity to work on projects supporting leading pharmaceutical companies and biotechs
• Career-track promotional opportunities