Roxanne Appleby
Midland,TX
Summary
Clinical data coordinator with extensive experience in managing clinical trial data, ensuring accuracy and compliance with industry standards. Demonstrates strong analytical skills and attention to detail, effectively coordinating multiple tasks simultaneously. Proven track record of improving data management processes, leading to enhanced efficiency and accuracy in clinical trial information.
Overview
23
23
years of professional experience
Work History
Clinical Data Coordinator
Professional Education & Research Institute
Blue Ash, Ohio
08.2025 - Current
- Review eCRFs in the database to ensure data consistency and completeness.
- Developed manual queries to resolve data discrepancies.
- Communicate potential data issues to the appropriate data management personnel.
- Identify data trends and report inconsistencies to applicable data.
- Collaborate with management to develop and implement actions to address.
- Assist in the creation of the DMP, eCCGs, Edit Check Specifications, data review listing specifications and other start-up documents.
- Executed ancillary reports to facilitate manual data and listing reviews for assigned studies.
- Review and respond to answered queries by the site and issue re-queries as needed.
- Collected and reported study metrics to track progress and outcomes.
Senior Clinical Data Associate
Advanced Clinical
Deerfield, IL
02.2023 - 12.2024
- Assisted in creating DMP, eCCGs, Edit Check Specifications, and data review listing specifications to ensure comprehensive study documentation.
- Review eCRFs in the database to ensure data consistency and completeness.
- Reconciled SAEs and external vendor data to maintain data integrity and support regulatory compliance for studies.
- Perform advanced aspects of the data cleaning process, with a high degree of accuracy and in accordance with GCPs and SOPs/WPDs.
- Perform Quality Control review.
- Communicate potential data issues to the appropriate data management personnel.
- Collaborate with management to develop and implement actions to address.
- Identify data trends and report inconsistencies to applicable data.
- Assist with EDC module integrations/setup (ePRO, Randomization, Dispensing, etc.).
- Ran ancillary reports used to perform manual data review and data listing review as defined on assigned studies.
- Created manual queries to identify data inconsistencies during the review process.
- Reviewed site queries and issued re-queries to ensure clarity.
- Collect and report on study metrics.
- Performed database closing, locking, and freezing processes to maintain data security.
- Executed EDC archival procedures to ensure organized management and secure retention of study data records.
Clinical Data Manager I
LabCorp Drug Development
Durham, NC
04.2020 - 09.2022
- Review Clinical Trial Data in accordance with Global Data Management Plans and applicable standardized data management process (Standard Operating Procedures and work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
- Generated, resolved, and tracked queries to address problematic data identified during data review activities and applied modifications to ensure database accuracy.
- Performed aggregate review of clinical data by patient, site, and project to identify trends and inconsistencies requiring further investigation.
- Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
- Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications.
- Assist in testing of data management system edit/data validation checks (diagnostics) and special listings/procedures used as tools for the data review and discrepancy management activities.
- Run ancillary reports (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
- Potentially interact and collaborate with other project and specialty team members (clinical programming, CDM technical support) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
- Potentially serve as client contact for project meetings and CDM status updates.
- Supported training of project staff on standardized data management processes to enhance project-specific compliance and effectiveness.
- Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application.
- Ability to effectively and efficiently manage multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads.
Clinical Research Data Coordinator II
California Cancer for Research and Excellence
Encinitas, CA
09.2015 - 04.2020
- Assisted Principal Investigator (PI), Sub Investigators (Sub-I’s), and Clinical Coordinators in executing Phase I-IV research protocols, ensuring compliance and protocol adherence.
- Maintained source documentation for all submitted data, ensuring accuracy and completeness of clinic or PI/Sub-I visit chart notes, lab reports, and procedure reports.
- Enter data into electronic data capture systems and submit Radiologic Scans (iMedidata, Rave, Inform, Bioclinica, Trial Master, eClinica, Oracle, Medrio) to protocol specific vendors accurately and timely.
- Interpretation of data (including appropriate source documentation) for entry into the computerized databases.
- Adhere to the International Council of Harmonization Good Clinical Practice, Health Insurance Portability and Privacy Act, National Institutes of Health, and Food and Drug Administration Regulations.
- Maintain contact and interact with monitors, sponsors and auditors.
- Coordinate lab kits with study nurses per protocol guidelines to ensure kit delivery to coordinate with research visits.
- Trained new employees on research protocols, data management, and facility processes, fostering a knowledgeable and compliant research team.
Clinical Research Data Coordinator II
Rocky Mountain Cancer Centers – US Oncology
Denver, CO
01.2004 - 08.2015
- Assisted Principal Investigator (PI), Sub Investigators (Sub-I’s), and Clinical Coordinators in executing Phase I-IV research protocols, ensuring adherence to study timelines and protocols.
- Maintain source documentation for all data submitted, including clinic or PI/Sub-I visit chart notes, lab reports and procedure reports.
- Assisted in conducting subject visits and documented adverse events and concomitant medications.
- Interpreted data and entered it into computerized databases, submitting Radiologic Scans to protocol-specific vendors with accuracy and timeliness.
- Adhere to the International Council of Harmonization Good Clinical Practice, Health Insurance Portability and Privacy Act, National Institutes of Health, and Food and Drug Administration Regulations.
- Maintained communication with monitors, sponsors, and auditors to facilitate compliance and address inquiries promptly.
- Coordinate lab kits with study nurses per protocol guidelines to ensure kit delivery to coordinate with research visits.
- Lead trainer to assist newly hired employees on research protocols, data management, and facility processes.
Medical Assistant I
Rocky Mountain Cancer Centers – US Oncology
Denver, CO
01.2003 - 01.2004
- Supportive role with responsibility and accountability for facilitating, communicating and collaborating with both the healthcare team and the patient.
- Collected vital signs, medication lists, and performed lab draws via intravenous access, centralized port access, and PICC line access to prepare patients for physician visits.
- Performed subcutaneous injections and started IV fluids – Hydrations.
- Assisted physicians with exams and bone marrow biopsies by preparing patients and ensuring slides were ready for specimen analysis.
- Maintained accurate chart documentation and medical records.
- Addressed patient inquiries using medical terminology to ensure clear understanding and effective communication.
- Performed clinical/technical skills specific to the department and assisted manager with projects.
- Processed all specimens for testing done in-house or prepared specimens to be shipped to an outside testing facility.
- Gathered/collected research specimens and processed them according to the protocol specifications.
Education
Medical Assisting -
Skadron College
San Bernardino, CA01-1989
General Education -
Eisenhower High
Rialto, CA01-1985
Skills
- Data management
- Clinical trial review
- Data management
- Query resolution
- Data quality control
- Query resolution
Timeline
Clinical Data Coordinator
Professional Education & Research Institute
08.2025 - Current
Senior Clinical Data Associate
Advanced Clinical
02.2023 - 12.2024
Clinical Data Manager I
LabCorp Drug Development
04.2020 - 09.2022
Clinical Research Data Coordinator II
California Cancer for Research and Excellence
09.2015 - 04.2020
Clinical Research Data Coordinator II
Rocky Mountain Cancer Centers – US Oncology
01.2004 - 08.2015
Medical Assistant I
Rocky Mountain Cancer Centers – US Oncology
01.2003 - 01.2004
Medical Assisting -
Skadron College
General Education -
Eisenhower High