Shaun Krueger

Act as primary safety specialist for assigned projects. Attend Kick-off meeting present safety processing and related guidelines knowledgeably. Ensure projects are set up as per protocol, contract and proposal. Quality checking the activities, ensuring high quality data is produced. Set up regulatory processes, ensuring that regulatory reporting team have all necessary contact detail for safety reporting. Set up and maintain tracker for all assigned projects. Production of Project Specific Work instructions (PSWI). Ensure all instructions are detailed and documented appropriately within the SMMP and/or PSWI. Keep abreast with the status and metrics of assigned projects and communicate any issues to team manager in a timely manner. Quality Checking of Data in safety database, narratives produced by junior staff, case QC and closure, QC safety-related paper documents/electronic data/database entries prepared by others, QC of CIOMs. SAE Reconciliation - Review data management listings, database reports, and validation checks. Attend internal weekly project meetings and ERMs, client meetings, and other appropriate meetings, as required, for assigned projects to alert senior manager of potential issues relating to the project. Audit attendance - Prepare for and attend audit meeting. Produce and review quarterly, periodic and annual safety reports, ensuring these are submitted to appropriate authorities on time. Mentoring junior colleagues. Study close-out activities. Consistently demonstrates the ability to undertake responsibilities at the next level. Participate in Grand Rounds (therapeutic training) and internal training program. Kept up-to-date in safety regulations, processes, and PPD's policy regarding safety issues etc. Adhered to PPD's corporate policies, SOPs, WPDs, other guidance documents, sponsor SOPs/directives and project specific WPDs. Adhered to current global ICH/local guidelines regarding clinical trials, regulatory documents, and safety issues. Developed and maintained a co-operative working relationship with project team members. Developed supervisory and mentoring skills. Delivered presentation to clients, investigators, and project team members on safety. Arranged project specific training to the project team and if required liaised with medical affairs personnel to deliver therapy area training to the team. Performs lead duties much as KPIs, monthly reports, STS/Argus reconciliation, QE audits, and submission synopsis.

• Acted as primary safety specialist for assigned projects. Attended Kick-off and Investigator meetings and presented safety processing and related guidelines knowledgably. Ensured projects were set up as per protocol, contract and proposal. Ensured that SMMP was approved prior FPFV(first patient, first visit). Quality checked the activities, ensured high quality data was produced. Set up regulatory processes, ensured that regulatory reporting team had all necessary contact detail for safety reporting. Set up and maintained tracker for all assigned projects. Production of Project Specific Work instructions (PSWI). Ensured all instructions were detailed and documented appropriately within the SMMP and/or PSWI. Set up and reviewed unblinding processes if required and ensured these were incorporated into SMMP along with necessary documentation. Liaised with safety tech ops staff to ensure set up of appropriate project schema within safety database and produced required data entry guidelines prior to FPFV. Kept abreast with the status and metrics of assigned projects and communicated any issues to team manager in a timely manner. Quality Checked Data in safety database, narratives produced by junior staff, case QC and closure, QC safety-related paper documents/electronic data/database entries prepared by others, QC of CIOMs. SAE Reconciliation - Reviewed data management listings, database reports, and validation checks. Attended internal weekly project meetings and ERMs, client meetings, and other appropriate meetings, as required, for assigned projects to alert senior manager of potential issues relating to the project. Audit attendance - Prepared for and attended audit meeting. Produced and reviewed quarterly, periodic and annual safety reports, ensuring these are submitted to appropriate authorities on time. Mentored junior colleagues. Studied close-out activities. Consistently demonstrated the ability to undertake responsibilities at the next level. Participated in Grand Rounds (therapeutic training) and internal training program. Kept up- to-date in safety regulations, processes, and IQVIA's policy regarding safety issues etc. Adhered to IQVIA's corporate policies, SOPs, WPDs, other guidance documents, sponsor SOPs/directives and project specific WPDs. Adhered to current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents, and safety issues. Developed and maintained a co-operative working relationship with project team members. Developed supervisory and mentoring skills. Delivered presentation to clients, investigators, and project team members on safety. Arranged project specific training to the project team and if required liaised with medical affairs personnel to deliver therapy area training to the team

Performed day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities included but were not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinated and performed Pharmacovigilance activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborated with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third-party vendors. Assisted in

the preparation of departmental and project-specific procedures and processes, prepared for and attended audits, kick-off and investigator meetings. Participated in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites. Reviewed regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintained medical understanding of applicable therapeutic area and disease states. Reviewed cases entered for quality, consistency and accuracy, including review of peer reports. Prepared and maintained regulatory safety reports. Assisted with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentored less experienced staff. Worked on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Developed professional expertise, applied company policies and procedures to resolve a variety of issues. Received general instructions on routine work, detailed instructions on new projects or assignments. Exercised judgment within defined procedures and practices to determine appropriate action. Contacts were primarily internal to the company with infrequent external customer / vendor contact on routine matters. Built productive internal / external working relationships.

• Managed and operated mechanical ventilators to deliver airway management.
• Managed ventilator support for critically ill patients in intensive care units, ensuring proper adjustments according to physician orders and clinical guidelines.
• Administered oxygen therapy, aerosol therapy and inhalation therapy to improve patients' breathing and lung function.
• Provided emergency response assistance in cases of respiratory distress or failure as part of a rapid response team.
• Assessed, diagnosed, and treated breathing issues.
• Educated patients and families on disease management, breathing techniques, and medication administration, promoting self-care and adherence to treatment plans.
• Performed bronchial hygiene techniques to remove mucus and secretions from patient lungs and improve lung function.
• Collaborated closely with interdisciplinary teams to develop comprehensive care plans addressing patient needs and goals.
• Provided antibiotics, bronchodilators, and anti-inflammatory medications with hand-held nebulizers, metered-dose inhalers and positive pressure equipment.
• Aided physicians with various procedures such as bronchoscopies, ventilator management, and intubations.
• Educated patients and families on proper use of respiratory equipment and techniques for managing respiratory disorders to improve patient outcomes.
• Served as a resource for staff and patients on the safe use of supplemental oxygen, ensuring optimal therapeutic benefits.
• Maintained accurate patient records to track patients' medical history and treatment plans.
• Delivered treatment for patients experiencing chronic and acute respiratory illnesses by conducting assessments and providing diagnoses.
• Developed strong relationships with referring physicians by providing timely communication regarding patient progress and updates on therapy effectiveness.
• Improved patient care by developing individualized treatment plans based on thorough assessments and evaluations.
• Enhanced patient outcomes by effectively administering respiratory therapy treatments and interventions.
• Monitored patient's physiological responses to therapy such as vital signs, arterial blood gases, and blood chemistry changes.
• Collaborated with physicians and other healthcare professionals to develop and implement patient treatment plans.
• Cooperated and communicated with physicians to deliver patient satisfaction and meet compliance with set standards.
• Ensured patient safety with diligent monitoring of vital signs during therapeutic interventions.
• Streamlined clinical processes through the implementation of efficient protocols for respiratory care procedures.
• Tested pulmonary function and analyzed arterial blood gas to identify abnormalities and issues with patient lung function.
• Optimized airway management by skillfully performing endotracheal intubations under challenging circumstances.
• Completed continued education units annually to stay current with respiratory therapy advancements and maintain compliance with administrative regulations.
• Provided comprehensive care to improve and strengthen clients' respiratory functions.
• Contributed to improved patient satisfaction scores by delivering compassionate and empathetic care throughout the treatment process.
• Promoted a positive workplace culture through active participation in department meetings, committees, and quality improvement initiatives.
• Monitored patient reactions to drugs and carefully documented findings.
• Kept abreast of industry advancements by attending continuing education courses, maintaining current knowledge of evidence-based practices.
• Implemented infection control measures within the facility to minimize risks associated with airborne pathogens.

• Managed and operated mechanical ventilators to deliver airway management.
• Administered oxygen therapy, aerosol therapy and inhalation therapy to improve patients' breathing and lung function.
• Provided emergency response assistance in cases of respiratory distress or failure as part of a rapid response team.
• Assessed, diagnosed, and treated breathing issues.
• Educated patients and families on disease management, breathing techniques, and medication administration, promoting self-care and adherence to treatment plans.
• Provided antibiotics, bronchodilators, and anti-inflammatory medications with hand-held nebulizers, metered-dose inhalers and positive pressure equipment.
• Educated patients and families on proper use of respiratory equipment and techniques for managing respiratory disorders to improve patient outcomes.
• Served as a resource for staff and patients on the safe use of supplemental oxygen, ensuring optimal therapeutic benefits.
• Maintained accurate patient records to track patients' medical history and treatment plans.
• Delivered treatment for patients experiencing chronic and acute respiratory illnesses by conducting assessments and providing diagnoses.
• Enhanced patient outcomes by effectively administering respiratory therapy treatments and interventions.
• Monitored patient's physiological responses to therapy such as vital signs, arterial blood gases, and blood chemistry changes.
• Collaborated with physicians and other healthcare professionals to develop and implement patient treatment plans.
• Tested pulmonary function and analyzed arterial blood gas to identify abnormalities and issues with patient lung function.
• Completed continued education units annually to stay current with respiratory therapy advancements and maintain compliance with administrative regulations.
• Monitored patient reactions to drugs and carefully documented findings.
• Kept abreast of industry advancements by attending continuing education courses, maintaining current knowledge of evidence-based practices.
• Implemented infection control measures within the facility to minimize risks associated with airborne pathogens.

• Managed and operated mechanical ventilators to deliver airway management.
• Managed ventilator support for critically ill patients in intensive care units, ensuring proper adjustments according to physician orders and clinical guidelines.
• Administered oxygen therapy, aerosol therapy and inhalation therapy to improve patients' breathing and lung function.
• Provided emergency response assistance in cases of respiratory distress or failure as part of a rapid response team.
• Assessed, diagnosed, and treated breathing issues.
• Educated patients and families on disease management, breathing techniques, and medication administration, promoting self-care and adherence to treatment plans.
• Performed bronchial hygiene techniques to remove mucus and secretions from patient lungs and improve lung function.
• Provided antibiotics, bronchodilators, and anti-inflammatory medications with hand-held nebulizers, metered-dose inhalers and positive pressure equipment.
• Aided physicians with various procedures such as bronchoscopies, ventilator management, and intubations.
• Educated patients and families on proper use of respiratory equipment and techniques for managing respiratory disorders to improve patient outcomes.
• Served as a resource for staff and patients on the safe use of supplemental oxygen, ensuring optimal therapeutic benefits.
• Maintained accurate patient records to track patients' medical history and treatment plans.
• Delivered treatment for patients experiencing chronic and acute respiratory illnesses by conducting assessments and providing diagnoses.
• Developed strong relationships with referring physicians by providing timely communication regarding patient progress and updates on therapy effectiveness.
• Monitored patient's physiological responses to therapy such as vital signs, arterial blood gases, and blood chemistry changes.
• Collaborated with physicians and other healthcare professionals to develop and implement patient treatment plans.
• Tested pulmonary function and analyzed arterial blood gas to identify abnormalities and issues with patient lung function.
• Optimized airway management by skillfully performing endotracheal intubations under challenging circumstances.
• Completed continued education units annually to stay current with respiratory therapy advancements and maintain compliance with administrative regulations.
• Implemented infection control measures within the facility to minimize risks associated with airborne pathogens.

• Developed and managed a high-performing respiratory therapy team to provide exceptional patient care.
• Encouraged positive financial habits by assessing prior year financial trends and variances and forecasting for current and future years to optimize monetary dealings.
• Spearheaded community outreach initiatives to raise awareness about respiratory health issues, prevention strategies, and available support resources for patients and families affected by chronic lung diseases.
• Enhanced staff competency through ongoing training, education, and professional development programs.
• Initiated organizational techniques to improve respiratory therapy services outcomes and developed information, strategies and changes for overall department direction.
• Educated medical care providers such as staff and nurses through seminars on critical respiratory care.
• Provided compassionate support to patients'' families during difficult times such as end-of-life decision-making or transitions into palliative care units.
• Promoted a culture of continuous improvement by encouraging open communication among team members about best practices, process improvements, and lessons learned from critical incidents or adverse events.
• Analyzed and reported on key departmental metrics to hospital leadership, demonstrating the impact of the respiratory therapy services on overall patient care quality and outcomes.
• Maintained and initiated communication and collaboration with physicians, care team leaders and staff nurses to develop, implement and evaluate plans of care for each patient.
• Established strong relationships with referring physicians, fostering collaboration in the management of respiratory patients across various clinical settings.
• Evaluated and assessed health care trends to establish new patterns of service based on vital measurements, productivity statistics and quality control outcomes.
• Ensured departmental compliance with all relevant regulations, accreditation standards, and hospital policies.
• Improved patient outcomes by implementing evidence-based respiratory therapy practices and protocols.
• Streamlined department operations by identifying areas for improvement and implementing efficient processes.
• Optimized resource utilization by regularly reviewing staffing levels, equipment availability, and budget allocations.
• Secured funding for advanced equipment purchases through effective grant writing and budget proposal submissions.
• Evaluated new technologies and therapy modalities to ensure the department remained at the forefront of innovative patient care delivery.

• Championed a positive work environment by fostering open dialogue between educators, clinicians, administrators, and other stakeholders involved in the delivery of patient care.
• Strengthened relationships with external partners such as universities or professional associations by coordinating joint educational initiatives.
• Evaluated clinical competencies of staff members, identifying areas for improvement and providing targeted training solutions.
• Optimized patient care quality by updating policies, procedures, and protocols based on current best practices in clinical education.
• Implemented innovative teaching techniques, such as simulation-based learning, to improve overall understanding of complex medical concepts.
• Increased patient satisfaction through effective communication and collaboration with interdisciplinary teams.
• Collaborated with management to assess learning needs and develop customized training plans for various departments.
• Facilitated continuing education events for healthcare professionals, fostering a culture of lifelong learning within the organization.
• Boosted employee retention through engaging professional development opportunities focused on skill enhancement and career growth.
• Enhanced staff proficiency in clinical procedures through hands-on demonstrations and interactive workshops.
• Served as a clinical mentor, offering guidance and support to new hires during their onboarding process.
• Improved patient outcomes by delivering comprehensive clinical education and training to healthcare providers.
• Participated in interdisciplinary committees, collaborating with peers to address challenges related to patient care and safety initiatives.
• Promoted evidence-based practices by conducting research and integrating current findings into educational programs.
• Instructed and coached students to help overcome academic issues and personal challenges.
• Implemented instructional presentations to communicate coursework goals.
• Improved student performance by defining clear goals and communicating performance metrics.
• Supervised students when administering medications to maintain patient safety.
• Provided immediate and constructive feedback to students individually and as group.
• Analyzed clinical settings' success in helping students achieve course and program outcomes.

• Managed and operated mechanical ventilators to deliver airway management.
• Managed ventilator support for critically ill patients in intensive care units, ensuring proper adjustments according to physician orders and clinical guidelines.
• Administered oxygen therapy, aerosol therapy and inhalation therapy to improve patients' breathing and lung function.
• Provided emergency response assistance in cases of respiratory distress or failure as part of a rapid response team.
• Educated patients and families on disease management, breathing techniques, and medication administration, promoting self-care and adherence to treatment plans.
• Performed bronchial hygiene techniques to remove mucus and secretions from patient lungs and improve lung function.
• Provided antibiotics, bronchodilators, and anti-inflammatory medications with hand-held nebulizers, metered-dose inhalers and positive pressure equipment.
• Aided physicians with various procedures such as bronchoscopies, ventilator management, and intubations.
• Educated patients and families on proper use of respiratory equipment and techniques for managing respiratory disorders to improve patient outcomes.
• Served as a resource for staff and patients on the safe use of supplemental oxygen, ensuring optimal therapeutic benefits.
• Maintained accurate patient records to track patients' medical history and treatment plans.
• Delivered treatment for patients experiencing chronic and acute respiratory illnesses by conducting assessments and providing diagnoses.
• Developed strong relationships with referring physicians by providing timely communication regarding patient progress and updates on therapy effectiveness.
• Enhanced patient outcomes by effectively administering respiratory therapy treatments and interventions.
• Monitored patient's physiological responses to therapy such as vital signs, arterial blood gases, and blood chemistry changes.
• Collaborated with physicians and other healthcare professionals to develop and implement patient treatment plans.
• Cooperated and communicated with physicians to deliver patient satisfaction and meet compliance with set standards.
• Ensured patient safety with diligent monitoring of vital signs during therapeutic interventions.
• Tested pulmonary function and analyzed arterial blood gas to identify abnormalities and issues with patient lung function.
• Optimized airway management by skillfully performing endotracheal intubations under challenging circumstances.
• Completed continued education units annually to stay current with respiratory therapy advancements and maintain compliance with administrative regulations.
• Contributed to improved patient satisfaction scores by delivering compassionate and empathetic care throughout the treatment process.
• Mentored new hires and students in respiratory therapy best practices, contributing to a high-quality work environment.
• Kept abreast of industry advancements by attending continuing education courses, maintaining current knowledge of evidence-based practices.
• Reduced readmission rates, providing thorough follow-up care and patient education on preventative measures.
• Improved patient satisfaction by quickly addressing concerns and adjusting treatment plans as necessary.
• Facilitated smoother transitions from hospital to home care for patients, coordinating with external healthcare providers.
• Improved patient outcomes by educating families on home care techniques and importance of medication adherence.
• Achieved significant improvements in treatment efficacy by leveraging advanced respiratory therapy technologies.
• Supported surgical teams during complex procedures, ensuring optimal patient breathing support.
• Performed arterial blood gas analysis and assisted in bronchoscopies.
• Maintained patient charts and information, strictly adhering to HIPAA laws and privacy guidelines.
• Conducted tests such as EKGs and drainages.

• Enhanced patient care by implementing advanced life support techniques and protocols.
• Led paramedic team during complex medical emergencies, providing clear direction and ensuring effective teamwork for successful outcomes.
• Collaborated with multidisciplinary teams during mass casualty incidents, ensuring timely triage, treatment, and transport of victims.
• Delivered high-quality pre-hospital care, effectively assessing, diagnosing, and treating patients in emergent situations.
• Maintained operational readiness of ambulance fleet through meticulous equipment inspections and inventory management.
• Provided compassionate end-of-life care, supporting patients and families during challenging moments.
• Mentored junior paramedics, sharing clinical knowledge and best practices to ensure their professional growth and development.
• Assisted with the review and revision of EMS policies and procedures to reflect current best practices in pre-hospital care.
• Contributed to a culture of safety by consistently identifying, reporting, and addressing potential risks during both emergency response operations and daily station activities.
• Supported regional disaster response initiatives as an active member of a highly trained mobile medical team specializing in large-scale incidents.
• Enhanced community health by participating in public education events on topics such as CPR, first aid, and injury prevention.
• Strengthened relationships with local fire departments through regular joint training exercises focused on scene safety and coordinated efforts in emergency response scenarios.
• Safeguarded patient privacy through strict adherence to HIPAA regulations during all interactions with patients and healthcare providers.
• Facilitated seamless patient handoff to hospital personnel, providing thorough reports and coordinating ongoing care needs.
• Exceeded state-mandated continuing education requirements, ensuring up-to-date knowledge of the latest advancements in emergency medicine and patient care techniques.
• Delivered advanced cardiac life support (ACLS), basic life support (BLS), and pediatric advanced life support (PALS) under pressure.
• Transferred patients safely and securely to medical facilities for continued care.
• Evaluated patient vital signs and status to determine care needs using pulse oximeters and electronic vital sign machines.
• Worked en-route to hospital to prepare patients for arrival or surgery and control wounds.
• Assessed patient condition through physical and verbal exams and by collecting information from others at scene.
• Conducted equipment and vehicle checks to maintain continuous and safe operation.
• Identified appropriate medications based on potential interactions with other medicines, accurately calculating correct dosages according to drugs on hand and patient's weight.
• Adapted treatment plans quickly and effectively based on changing patient conditions and reactions.
• Developed and maintained rapport with coworkers and local hospital staff to facilitate efficient patient care.
• Triaged injuries by communicating with patients, bystanders and family members and identified appropriate medical facility for transport.
• Responded to daily emergencies and worked alongside firemen and EMTs.
• Administered fluid replacement via IV, IO, and IM to replace fluid volumes and correct electrolyte imbalances.
• Delegated life-saving tasks to provide comprehensive treatment to triaged patients in emergency situations.
• Administered continuous 12-lead electrocardiogram monitoring to record heart rhythms in patients with acute coronary syndrome.
• Performed intubations to secure airway in patients under respiratory and cardiac arrest.
• Maintained patient care, treatment and medication documentation for accurate, up-to-date clinical records.
• Restocked ambulance with proper equipment such as vents, ET tubes, medication, and IV pump tubing to maintain optimum inventory.
• Communicated with medical professionals in medical terms to relay patient needs and maintain accuracy.
• Responded to emergency calls to provide immediate and life-saving medical care.
• Documented patient information, medical interventions and patient outcomes for accurate record-keeping.
• Attended training classes to maintain certification licensure, keep abreast of new developments in field and maintain existing knowledge.
• Transported critically ill and injured patients to nearest medical center, using advanced life support equipment as needed.
• Took patient health histories and asked questions to determine cause of illness or injury.
• Operated electrocardiograms (EKGs), external defibrillators or bag valve mask resuscitators in advanced life support environments.
• Monitored patients' vital signs to assess condition and identify necessary medical interventions.
• Trained new paramedics on proper procedures and protocols to maintain best practices and promote great patient care.
• Conducted end-of-shift cleaning, sanitation and resupply of equipment to promote organized, sanitary workstation.
• Liaised with police, fire department and other emergency responders to manage emergency scenes.
• Provided CPR and used automated external defibrillators (AEDs) to revive patients in cardiac arrest.
• Used defibrillators and oxygen tanks during patient care and transport, increasing chances of survival.
• Placed patients on backboards or stretchers to safely load into ambulance.

• Self-motivated, with a strong sense of personal responsibility.
• Worked effectively in fast-paced environments.
• Skilled at working independently and collaboratively in a team environment.
• Proven ability to learn quickly and adapt to new situations.
• Excellent communication skills, both verbal and written.
• Worked well in a team setting, providing support and guidance.
• Demonstrated respect, friendliness and willingness to help wherever needed.
• Assisted with day-to-day operations, working efficiently and productively with all team members.
• Passionate about learning and committed to continual improvement.
• Worked flexible hours across night, weekend, and holiday shifts.
• Managed time efficiently in order to complete all tasks within deadlines.
• Organized and detail-oriented with a strong work ethic.
• Paid attention to detail while completing assignments.
• Used critical thinking to break down problems, evaluate solutions and make decisions.
• Strengthened communication skills through regular interactions with others.
• Adaptable and proficient in learning new concepts quickly and efficiently.
• Learned and adapted quickly to new technology and software applications.
• Proved successful working within tight deadlines and a fast-paced environment.
• Developed and maintained courteous and effective working relationships.
• Demonstrated strong organizational and time management skills while managing multiple projects.
• Special Force Medic
• Paratrooper
• Diver
• Bronze Star recipient