Karolina Świątek

Start-up I Oncology I Medical Devices

• Enhanced patient recruitment by developing targeted outreach strategies for diverse populations.
• Streamlined clinical trial processes by implementing efficient data management systems and documentation practices.
• Reduced study timelines by effectively coordinating efforts between cross-functional teams and external vendors.
• Ensured compliance with regulatory guidelines, maintaining accurate and up-to-date records throughout all phases of the trial.
• Optimized study outcomes by closely monitoring patient safety, adverse events, and protocol deviations.
• Facilitated improved site performance with ongoing training sessions and timely feedback to clinical staff members.
• Developed strong relationships with site personnel, fostering a collaborative environment conducive to successful trial execution.
• Assisted in the preparation of high-quality regulatory submissions, including informed consent forms, ethics committee applications, and safety reports.
• Contributed to the development of robust study protocols by providing input on design elements, feasibility assessments, and operational considerations.
• Collaborated with data management teams to ensure accurate and timely entry of clinical trial data into the appropriate electronic systems.
• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Gathered, processed, and shipped lab specimens.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Followed informed consent processes and maintained records.
• Monitored unit budget to meet financial objectives for spend rate and funding.
• Conducting site initiation visits and on-site monitoring visits
• Cooperation with a consulting company in preparing an application to the FDA
• Conducting contract and budget negotiations

Control of medical records in the use of direct coercion

• Collaborated with cross-functional teams to achieve project goals on time and within budget.
• Rating daily hospital reports as well as elaborating, excluding errors in reporting direct coercions according to local law
• Earned recognition as a top performer consistently exceeding targets throughout my tenure as a specialist in the field.
• Followed all company policies and procedures to deliver quality work.
• Listened and responded to customer requests and forwarded necessary information to superiors.
• Assisted with staff training to enforce quality, safety and sanitation guidelines.
• Created and delivered presentations to internal and external stakeholders to showcase work.
• Monitored industry trends to adapt strategies accordingly.
• Collected, arranged, and input information into database system.
• Educated staff on organizational mission and goals to help employees achieve success.

Phase 2, 3 and 4 studies in the field of gastroenterology, nephrology, neurology, immunology, cardiology, dermatology and orthopedics areas

• Developed comprehensive reports for senior management, enabling informed decision-making based on data-driven insights.
• Streamlined vendor management processes, facilitating improved relationships and timely service deliveries.
• Enhanced operational workflows by maintaining well-organized documentation systems and updating records accurately as needed.
• Oversaw scheduling tasks efficiently, ensuring optimal staff coverage during peak times without sacrificing quality of service delivery or exceeding budget constraints.
• Entered data, generated reports, and produced tracking documents.
• Resolved issues through active listening and open-ended questioning, escalating major problems to manager.
• Kept high average of performance evaluations.
• Increased efficiency by streamlining coordination processes and implementing new organizational systems.
• Managed project timelines for successful completion, ensuring milestones were met and deadlines were adhered to.
• Improved team productivity with regular communication and progress updates, fostering a collaborative work environment.
• Coordinated cross-functional teams, resulting in seamless project execution and enhanced outcomes.

Phase 2,3 and 4 of hematooncology clinical trial area

• Enhanced patient recruitment by developing and implementing targeted advertising strategies.
• Optimized trial efficiency through meticulous data management and timely report submissions.
• Ensured patient safety by closely monitoring adverse events and promptly reporting to regulatory agencies.
• Streamlined communication channels, fostering strong relationships with investigators, sponsors, and clinical teams.
• Maintained strict adherence to study protocols, contributing to high-quality trial outcomes.
• Conducted rigorous pre-screening assessments of potential trial participants, ensuring eligibility criteria were met.
• Facilitated timely resolution of protocol deviations by collaborating with relevant stakeholders and implementing corrective measures.
• Established a system for tracking participant follow-up visits, minimizing drop-out rates and improving retention throughout trials.
• Played an active role in preparing sites for audit visits from regulatory authorities ensuring compliance at all times.
• Maintained a strong understanding of industry trends and regulatory updates, ensuring clinical trials remained compliant with evolving requirements.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Followed informed consent processes and maintained records.
• Collected, evaluated, and modeled collected data.

• Enhanced trainee experience by developing comprehensive orientation programs and hands-on training sessions.
• Increased trainee retention rate by conducting regular check-ins and providing constructive feedback.
• Streamlined the onboarding process for new trainees, reducing time to productivity.
• Developed strong working relationships with trainees, fostering a supportive learning environment.
• Established open lines of communication with managers regarding employee growth opportunities after completing the program.
• Continuously refined course content based on feedback from trainees and evolving industry trends, ensuring up-to-date knowledge for future participants.
• Learned new materials, processes, and programs quickly.

• Improved community health by developing and implementing targeted educational programs.
• Raised awareness of public health issues through organizing workshops, seminars, and presentations.
• Enhanced patient outcomes by providing one-on-one counseling on health behaviors and disease management.
• Collaborated with healthcare professionals to create comprehensive patient education materials for various medical conditions.
• Conducting an educational module in the #ZDROWIE program for high school students.
• Gave public talks on importance of health education and specific disease prevention and treatment strategies.

• Enhanced intern productivity by assisting with project coordination and providing ongoing support.
• Streamlined office processes for improved efficiency and time management through regular organization and filing.
• Contributed to a positive team environment by collaborating with fellow interns on group projects and presentations.
• Supported staff members in their daily tasks, reducing workload burden and allowing for increased focus on higher-priority assignments.
• Experience in coding and accounting for hospital wards