Assistant CRA

• Perform remote activities on assigned clinical research projects in liaison with the CRA and study Clinical Lead
• Support site preparedness and the logistics of 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 orientation on study 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 qualification processes and site staff system access
• Follow up on site staff training
• Coordinate logistics for investigator meeting attendance
• Maintain vendor trackers and coordinate study/site supplies
• Collect, review, and update essential documents in applicable 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 involving CRF and query status, deviations, SAEs, and safety reports
• Verify document collection status and follow up on missing, incomplete, expired, or open documents
• Perform other assigned site management tasks and possible 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 and 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, with strong attention to detail and ability to handle multiple tasks efficiently
• 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 Microsoft 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
• Standard Monday–Friday work schedule
• Occasional travel to clinics/hospitals may be required
• Opportunity for career progression into CRA roles, which may include direct promotional opportunities
• Exposure to global clinical research projects across 100+ countries