Assistant CRA – FSP

• Perform remote activities on assigned clinical research projects in liaison with the CRA and study Clinical Lead
• Support site preparedness and monitoring logistics
• Assist with site management and remote monitoring 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 orient users on study-specific systems
• Provide in-house support for pre-study assessments and 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, site EDL, and site information
• Review patient-facing materials and translations
• Support vendor qualification, system access, site staff training, and IM attendance logistics
• Maintain vendor trackers and coordinate 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
• Coordinate site payment processes, system updates, reconciliations, and site invoice follow-up
• Perform reconciliation tasks for CRFs, queries, deviations, SAEs, and safety reports
• Drive action for missing, incomplete, or expired documents and open document findings
• Perform other assigned site management tasks and FSP-specific 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
• Previous experience in oncology clinical studies is required, preferably in roles such as CTC, PSC, or Study Coordinator
• 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, attention to detail, and ability to handle multiple tasks efficiently
• Flexibility and adaptability
• Ability to work independently or as part of 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
• Ability to extract pertinent information from study documents, electronic study data systems, CTMS, and dashboards
• Excellent English language and grammar skills
• Ability to work in an office or home office environment; occasional travel to clinics/hospitals may be required

• Fully remote work
• Standard Monday–Friday work schedule
• Home office environment
• Occasional travel to clinics/hospitals may be required
• Opportunity to work with a global team and support clinical trials for leading pharmaceutical and biotechnology companies