Assistant CRA – FSP

• Perform remote site management and monitoring activities on assigned projects
• Review study data from various sources remotely
• Contact study sites to collect study documentation, resolve issues and request outstanding information
• Maintain collaborative communication with site staff regarding protocol conduct, enrollment, EDC completion, queries and site performance
• Track and follow up on subject data in EDC and other applicable systems
• Raise manual queries in EDC when applicable
• Remotely review study logs
• Conduct and document site management calls and contacts
• Participate in investigator meetings
• Investigate and follow up on centralized monitoring findings
• Evaluate PI oversight, subject safety and study processes
• Conduct remote risk-based investigations into site performance and support corrective/preventive actions
• Provide refresher training and follow up on outstanding regulatory and administrative documents
• Review clinical listings and track/trend violations, deviations, site status, enrollment, CRF status and SAE follow-up
• Provide trial status tracking and progress reports to the study manager
• Participate in investigator payment processes, if applicable
• Liaise with internal staff to collect documents and review data and findings
• Help ensure audit-ready files and CTMS/eTMF data stewardship
• Contribute to company, client and regulatory audit responses

• Bachelor’s Degree in a life science-related field
• Prior clinical research experience 0-1 year, or equivalent knowledge through classwork/training
• Knowledge of clinical monitoring through classwork/training
• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain working knowledge of ICH GCPs, applicable regulations and PPD procedural documents
• Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP)
• Ability to successfully complete the RSM Onboarding Workshop
• Fluency in German and English languages (minimum C1 Level)
• Ability to evaluate medical research data
• Good organizational and time management skills
• Strong attention to detail
• Critical thinking, root cause analysis and problem-solving skills
• Good computer skills and good knowledge of MS Office
• Ability to extract pertinent information from study documents, electronic study data systems, CTMS and dashboards

• 2 Year Fixed Term contract
• Full-time (40 hours/week)
• Flexible working models that support work-life balance
• Clear development pathways (e.g., Senior CRA, Lead CRA, CTM)
• Award-winning learning and development programme
• Competitive salary
• Extensive benefits package based around the health and well-being of employees
• Flexible working culture
• Collaborative environment
• Teams of colleagues eager to share expertise and have fun together