Katherine Owens
Prattville,AL
Summary
Multi-talented clinical research professional proficient in handling patient information, laboratory samples and compliance procedures for clinical trials. Eclectic background including 10 years of high complexity laboratory experience from benchwork to management. Well-organized and hardworking with excellent communication and troubleshooting skills. Experienced with multiple EHR and LIMS databases and multiple data analysis softwares. Current CHS certification (certified histocompatibility specialist stemming from robust organ transplant laboratory background).
Overview
9
9
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
No Resistance Consulting Group
Montgomery, AL
09.2023 - Current
- Compiled trial related documents into electronic data as required by sponsor or regulatory agency.
- Maintained accurate and timely study databases.
- Performed patient assessments, collected and analyzed data, and prepared reports.
- Maintained SOPs and Good Clinical Practice in compliance with regulatory guidelines.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Provided training to study staff on protocol requirements and GCP regulations.
- Collected, processed and delivered specimens from trial participants.
- Conducted screening interviews to determine eligibility of possible subjects.
- Educated participants on studies and anticipated outcomes.
- Reviewed CRFs for completeness and accuracy before database entry.
Lead Laboratory Scientist
Clearway Pain Solutions
Montgomery, AL
02.2023 - 09.2024
- Manage toxicology laboratory clinic staff as well as central lab staff.
- Develop and lead trainings for clinic workflows and new laboratory softwares and interfaces.
- Provided training and created training materials.
- Appropriately used Athena (EHR) and Apollo (LIMS) to accurately report patient results.
- Performed instrument calibration, validation, and managed appropriate data transfer.
- Manage lab inventory for remote clinics and central lab.
- Main point of contact for providers seeking lab result interpretation.
- Reviewed and signed off on urine toxicology screenings performed on Mindray chemistry analyzer.
- Validated new toxicology instruments and managed service contracts.
- Kept excel spreadsheet documentation of weekly and monthly sample volume.
- Prepared new clinics for lab setup (setting up overnight sample shipping, ordering supplies, setting up LIMS accounts and interfaces).
- Maintained all important documents for CLIA inspection and maintains, performs, and enters data for CAP compliance for drugs of abuse and urine toxicology.
- Utilize CPT codes for reference lab testing and billing.
Certified Histocompatibility Specialist (CHS)
UAB Medicine
Birmingham, AL
04.2015 - 02.2023
- Perform daily bench duties in laboratory that include complex molecular assays such as flow cytometry, SAB/LSA/LMID antibody testing, and RTPCR as they pertain to solid organ and bone marrow transplant.
- Develop flow charts, spreadsheets, and documentation related to clinical trials and research projects related to transplant.
- Point of contact for transplant related clinical trials.
- Lead research projects within the lab and provide input to program coordinators.
- Respond to 24 hour on-call needs of the lab on a rotating schedule with other technologists.
- Daily communication with laboratory director, surgeons, and other members of the transplant team to report stat testing results.
- Data analysis using SAS and Excel to compile patient antibody profiles and other transplant related testing and information.
- Perform laboratory inventory and keep detailed PM logs, QA/QC material, SDS sheets, and SOPs in order.
- Ensures quality by performing instrument QC, validation, PM logs, good laboratory practice, and ensuring proper data transfer from instrument to softwares.
- Extensive use of Cerner (EHR) and Histotrac (LIMS).
Education
Master of Public Health - Epidemiology
University of Alabama At Birmingham
Birmingham, AL04-2022
Bachelor of Science - Molecular Biology
University of Alabama At Birmingham
Birmingham, AL04-2014
Skills
- Clinical research
- Laboratory results managmenet
- PCR & RTPCR with DNA extraction
- Data Analysis
- LIMS and EHR
- HL7 interfaces
- Good laboratory practice (GLP)
- Employee training
- Flow cytometry, immunological, and toxicology assays
- Survey development
- QA/QC with CAP compliance
- Knowledge of hospital systems and standards of care
- Protocol Development
- LIMS troubleshooting
- Specimen Handling
Certification
- CHS - Certified histocompatibility specialist (ACHI)
Valid December 2023 – December 2026
Contributions to Science
- Performed antibody detection and flow cytometry analysis of xeno transplant as an answer to solid organ shortage
Porrett PM, Orandi BJ, Kumar V, Houp J, Anderson D, Cozette Killian A, Hauptfeld-Dolejsek V, Martin DE, Macedon S, Budd N, Stegner KL, Dandro A, Kokkinaki M, Kuravi KV, Reed RD, Fatima H, Killian JT Jr, Baker G, Perry J, Wright ED, Cheung MD, Erman EN, Kraebber K, Gamblin T, Guy L, George JF, Ayares D, Locke JE. First clinical-grade porcine kidney xenotransplant using a human decedent model. Am J Transplant. 2022 Jan 20. doi: 10.1111/ajt.16930. Epub ahead of print. PMID: 35049121
Timeline
Clinical Research Coordinator
No Resistance Consulting Group
09.2023 - Current
Lead Laboratory Scientist
Clearway Pain Solutions
02.2023 - 09.2024
Certified Histocompatibility Specialist (CHS)
UAB Medicine
04.2015 - 02.2023
Master of Public Health - Epidemiology
University of Alabama At Birmingham
Bachelor of Science - Molecular Biology
University of Alabama At Birmingham
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