Katherina Kyles
Lynwood,IL
Summary
Results-driven Clinical Research Coordinator known for productivity and efficiency in task completion. Skilled in patient recruitment, regulatory compliance, and data analysis to ensure smooth operation of clinical trials. Excel at communication, teamwork, and problem-solving, using these soft skills to navigate challenges and drive projects to completion. Always focused on advancing research goals with precision and integrity.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator II
Rush University Medical Center, RUMC
Chicago, IL
07.2023 - Current
- Manages participant recruitment, consent process, screening, scheduling and tracking for the study.
- Maintained accurate and up-to-date records through the collection and entry of data into study case report forms or electronic data capture system, promptly addressing any queries.
- Submits or partners with a regulatory coordinator to submit study related documents, study protocols and study protocol amendments to the IRB per policy and procedure.
- Ensures that procedural documentation for clinical research adheres to institutional, local, state, and federal guidelines and regulations with accuracy and completeness.
- Ensured the collection, processing, and shipment of potentially biohazardous specimens.
- Employed advanced testing methods to ensure accurate data collection.
- Created summary reports for distribution to key stakeholders including PI, Administrator, Office of Research Affairs, Sponsor, and Compliance.
- Managed the reporting of unexpected issues such as protocol deviations, adverse events, and serious adverse events.
- Collaborated with PI(s), sponsor, compliance personnel, clinical staff, and manager to analyze and enhance intricate research study processes.
- Assisted in developing the skills of junior team members through supervision and guidance.
- Developed and maintained accurate and timely study databases.
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Provided training to study staff on protocol requirements and GCP regulations.
Associate Clinical Research Coordinator
Rush University Medical Center, RUMC
Chicago, IL
12.2021 - 07.2023
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Developed study protocols and data collection tools, ensuring compliance with regulatory standards
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Screened patient records and databases to identify prospective candidates for research studies.
- Followed informed consent processes and maintained records.
- Gathered, processed and shipped lab specimens.
- Carried out day-day-day duties accurately and efficiently.
- Demonstrated respect, friendliness, and willingness to help wherever needed.
- Worked flexible hours; night and weekend shifts.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Developed and maintained courteous and effective working relationships.
- Offered friendly and efficient service to study participants, handled challenging situations with ease.
Technical Research Assistant
Alzheimer's Association
Chicago, IL
11.2011 - 08.2021
- Gathered and organized information for research purposes.
- Organized all subject data and changes, in multiple databases.
- Identified problems and performed troubleshooting and analysis to refine or adapt procedures.
- Performed research into study topics to increase knowledge and to provide valuable contributions.
- Collaborated with team members to initiate best practices to achieve organizational goals.
- Streamlined research processes to meet tight deadlines for multiple projects.
- Led special projects through effective emergency resolution by diminishing obstacles and saving time.
- Interacted with study participants during recruitment calls by preparing for questions pertaining to eligibility criteria for studies.
- Implemented training process improvements for staff.
Education
Purdue University Global
Completed 90 credits towards a BS in PsychologySkills
- Research experience
- Documentation requirements
- Trial oversight
- Protocol development
- Phlebotomy
- Specimen handling
- Database organization
- Site Management
Certification
- Certified Phlebotomist, Chicago School of Phlebotomy
- Certified Advanced Clinical Trial Assistant, Certified Clinical Research Professionals Society
Timeline
Clinical Research Coordinator II
Rush University Medical Center, RUMC
07.2023 - Current
Associate Clinical Research Coordinator
Rush University Medical Center, RUMC
12.2021 - 07.2023
Technical Research Assistant
Alzheimer's Association
11.2011 - 08.2021
Purdue University Global
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