Essential Document Specialist Jobs

• Work with internal/external partners to confirm document processing times are maintained
• Apply creative solutions to complex site ready situations and demonstrates situational leadership within cross functional teams. Interact with external partners for programmatic and functional sourcing
• Assist in retrieval of documentation during sponsor inspections
• Liaise with clinical teams and external partners to achieve site ready timeline
• Monitor/track compliance of study essential documents
• Recognize and consider various solutions to problems or situations
• Support strategies, procedures, and tools for the optimization of the processes
• Confirm the integrity of the essential clinical trial documents (both hardcopy and electronic) within the Official Regulatory files
• Work with inspection support teams to maintain inspection process readiness
• Confirm that all actions and commitments are implemented in a timely manner
• Interface with staff members to provide support and guidance
• Support the development of responses to audits and inspections and confirms appropriate implementation
• Maintain proper communication with external partners, stakeholders and customers
• Identify and review metrics to maintain efficient and effective process

• MS Outlook - oversee processing of study document requests from cross-functional team members to ensure that all urgent requests and inquiries are being handled in a timely manner for all assigned and unassigned studies
• MS Excel: Batching, Scanning, Indexing, Importing, Searching, Rework, and generate excel reports
• MS Word: Mail merging - documents, letter, labels; document formatting, inserting section breaks and other documents (templates) within a document
• MS Access: Running queries
• UPS: generating UPS labels

Experience:

• A minimum of 2 years of relevant experience in clinical research, direct eTMF experience
• Must have a general understanding of the functional area responsibilities associated with the clinical development process, trial management, and clinical trial management systems, as well as quality management and control tools.
• General knowledge of ICH-GCP and other relevant regulations pertaining to essential documents

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.