Daniel Thomas Luppus

Key responsibility as a Clinical Research Associate are currently:

• As a Primary-CRA (CRA II) in several studies acting as primary point of contact for Sponsor, Vendors,
  CRAs and other departments, for clarifications and guidance of new CRAs.
• Guidance and training for new employees. Active participation in job interviews and performance
  evaluation of new employees. Responsible for the technical and methodological training of interns and
  new employees with a focus on efficient and sustainable employee development, mentoring, including
  the successful transfer of interns to active positions after onboarding.
• Delivering quality, timely monitoring reports for sponsor approval per the Clinical Operation Plan (COP)
  timelines.
• Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at
  assigned sites as dictated by ICH-GCP, protocol and sponsor requirements.
• Monitoring (remote and on-site) with a focus on data integrity and subject safety in accordance with
  local / regional laws and country specific regulations.
• Conduct Site Selection, Initiation, Monitoring and Close-out Visits for Phase I to IV studies across various
  indications, including cancer, chronic diseases, rare diseases and psychiatric disorders, with a focus on data integrity and patient safety. On oncology studies working with RECIST 1.1 and mRANO.
• Managing query resolution process with sites and the Data Management Team.
• Maintaining electronic Trial Master File (eTMF) as defined by COP.
• Participating in Investigators’ Meeting.
• Communication with study sites and management team.
• Reviewing IP/Device accountability and applicable logs.
• Investigate Quality Issues, create CAPA plans in close collaboration with Quality Management Team,
  Sponsor and Site.
• Assisting the project team with assessing project feasibility and recruitment. Performing Team meetings.

• Project Management and Coordination: Managed and performed study-specific project tasks
  according to Protocol requirements, including project controlling, contract and budget negotiations.
• Stakeholder Communication: Liaised with Clinical Research Organizations (CROs), sponsors and
  Federal Supreme Authorities to ensure project alignment and regulatory compliance.
• Visit and Audit Organization: Organized and attended patient visits. Organized and attended prestudy
  visits, site selection visits (SSV), site initiation visits (SIV), monitoring visits, audits and round tables.
• Support for Clinical Research Associates (CRAs): Provided comprehensive support for CRAs during
  SIVs, monitoring visits, remote visits and other study-related activities.
• Compliance and Documentation: Implemented and developed SOPs, ensuring strict adherence
  to ICH-GCP guidelines and legal regulations, while creating study-specific documents. Maintained
  investigator site file (ISF).
• Patient and Laboratory Management: Conducted patient support, assessments, SAE reporting,
  interviews and managed laboratory activities, including the processing of biological samples.

• Management Responsibilities: Creation and optimization of night shift schedules for a 15-person team in the sleep laboratory, taking into account personnel resources and staffing requirements depending on workload and collective agreement specifications.
  
  Development of standardized documentation worksheets sleep logs (e.g., PSGs, MSLTs) for quality assurance and data consistency with a focus on increasing efficiency through standardization.
• Patient Assessment and Treatment: Evaluated medical histories, prioritized patient treatment, and
  managed patient admissions and discharges.
• Supervision and Mentorship: Supervised and mentored students and newly qualified nurses, ensuring
  high-quality care and professional development.
• Patient Care and Coordination: Provided care for patients of all ages, acted as the main point of contact,
  and coordinated with hospital managers and healthcare professionals to develop patient care plans.
• Medical Procedures and Administration: Performed tests, evaluations, and investigations,
  administered medications and utilized monitoring devices.
• Administrative Responsibilities: Managed patient records, updated documentation and maintained
  accurate treatment histories.

• Delivery of Nursing Services: Responsible for delivering basic and specialized nursing care, focusing on
monitoring long-term conditions, administering treatments for critical ill patients and advising on health
prevention.
• Patient Communication and Consent: Ensuring patients are fully informed about their treatment,
gaining their consent, and maintaining compassionate communication with patients and their families.
• Intensive and General Care: Working in intensive care unit, managing the care of ventilation patients
and performing and assisting in diagnostic and therapeutic procedures.
• Emergency and Monitoring: Implementation of emergency measures, including resuscitation and using
monitoring equipment and ventilator for patient surveillance and treatment.
• Patient Education, Support, and Staff Training: Educating patients on hygiene, health, and disease
prevention; providing support for seriously ill or dying patients and their relatives. Providing training and
supervision of new staff members.
• Infection Control: Strict adherence to isolation and protection measures for highly infectious diseases,
including work in COVID-19 ICU units.

• Patient Assessment and Treatment: Evaluated medical histories, prioritized patient treatment, and
  managed patient admissions and discharges.
• Supervision and Mentorship: Supervised and mentored students and newly qualified nurses, ensuring
  high-quality care and professional development.
• Patient Care and Coordination: Provided care for patients of all ages, acted as the main point of contact,
  and coordinated with hospital managers and healthcare professionals to develop patient care plans.
• Medical Procedures and Administration: Performed tests, evaluations, and investigations,
  administered medications and utilized monitoring devices.
• Administrative Responsibilities: Managed patient records, updated documentation and maintained
  accurate treatment histories.