Lenka Zoratto

- Prepare site regulatory documents, review of completeness and accuracy, EUCTR submissions

- Review, prepare and negotiate site contracts and budgets with sites

- Mentoring junior colleagues, coordination of junior team members activities in the study

- Site activation

- Completion and maintenance of internal systems, databases and tracking tools with project specific information

- Review, establish and agree on project planning and project timelines

- Provide local expertise to RSU leads and project team during initial and ongoing project timelines planning

- Review, track and follow up the progress, approval and execution of documents, including contracts, ICF and IP release documents, in line with project timelines

- Prepare site regulatory documents, review of completeness and accuracy, EUCTD/EUCTR submissions

- Review, prepare and negotiate site contracts and budgets with sites

- Site activation

Completion and maintenance of internal systems, databases and tracking tools with project specific information

- Review, establish and agree on project planning and project timelines

- Provide local expertise to CSA leads and project team during initial and ongoing project timelines planning

- Review, track and follow up the progress, approval and execution of documents, including contracts. ICF and IP release documents, in line with project timelines

- Assist the team in the preparation, handling, distribution, filing and archiving documentation

- Perform regulatory and start-up activities including contract and budget negotiations

- Prepare site regulatory documents, review of completeness and accuracy, EC submissions

- Completion and maintenance of internal systems, databases and tracking tools with project specific information

- Review, track and follow up the progress, approval and execution of documents, including contracts, ICFs and IP release documents, in line with project timelines

- Triage of incoming reports for legibility and validity

- Assessment of case reports for seriousness, causality and expectedness

- Adverse event and drug coding, writing narratives

- Create and maintain project specific files

- Help Medical Directors/Safety Physicians with medical monitoring activities such as collection and review of endpoint packages

- Review and follow up protocol violations

- Maintaining Q&A logs

- Maintaining translations of documents for Medical Department

- Personal assistant to the Head of Elementary School

- Communication source for ES faculty, parents and ISP staff

- Manage ES budgets

- Communicate and distribute information to faculty or parents (such as report cards, budget information, parent-teacher conferences)

- Updating ES website on ISP intranet

- Petty cash management, office orders, provision of basic services for the office, data analysis

- Solve emergency situations such as accidents or sudden teacher absences