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University of North Carolina Wilmington

*   Performed site initiation, interim, and close-out monitoring visits in accordance with ICH-GCP guidelines and applicable regulatory requirements.
*   Created innovative tracking tools to monitor and manage the progress of sites across multiple studies, optimizing oversight related to protocol adherence, regulatory, vendor access, pharmacy/IP, eTMF, and site files.
*   Demonstrated meticulous attention to detail with review of source documentation and performing source data verification to ensure the accuracy and reliability of clinical trial data.
*   Maintained 100% compliance with reporting requirements/timeframes for SAEs and unanticipated events across all sites.
*   Established and maintained strong working relationships with investigative sites, fostering open communication channels and contributing to a proactive approach in addressing study expectations and resolution of issues.
*   Oversaw successful resolution of critical site issues, applying quick and effective problem-solving strategies, leading to the prevention of further incidents.
*   Achieved an average of >98% compliance for assigned sites regarding data entry, query resolution, and PI signature metrics through establishment of routine communication and follow-up of outstanding items as needed.
*   Provided thorough documentation of study progress through site monitoring reports, follow-up letters, action items, and contact reports.
*   Administered protocol and study-related training to investigative sites and tracked training performed by the site.
*   Conducted detailed inspections of pharmacy equipment and SOPs, ensuring proper documentation, handling, storage, preparation, administration, and destruction of study drug.
*   Performed IP accountability and reconciliation to ensure compliance with protocol and IP specifications.
*   Evaluated the quality and integrity of site practices related to the conduct of the study and suggested best practices that reinforce ICH-GCP guidelines.

Clinical Research Associate

*   Completed a specialized CRC to CRA Oncology Bridge Program, demonstrating dedication to professional development and expansion of knowledge for oncology research.
*   Developed and maintained tracking system for the submission and filing of documents in eTMF.
*   Worked closely with other study team members to facilitate identification and timely resolution of issues as well as plan for preventing further incidents.
*   Ensured site personnel completed all required training with proper documentation prior to being delegated and performing any study-related tasks.
*   Completed monitoring activity activities as detailed in J&J SOPs and monitoring plan.
*   Verified accuracy of clinical trial data collected through source document review and verification.

*   Coordinated and managed the department’s highest-enrolling oncology trials.
*   Collaborated with Investigators, regulatory coordinators, investigational pharmacists, and other site staff on a regular basis.
*   Attended weekly meetings to discuss study progress and important updates.
*   Performed pre-screening and screening activities of potential trial participants, supporting departmental subject enrollment goals.
*   Obtained informed consent from trial participants consistent with ICH-GCP guidelines and regulatory requirements.
*   Built patient treatment plans in Epic which included orders for all required laboratory tests, assessments, and imaging to be completed per protocol.
*   Scheduled study visits and imaging appointments for subjects per protocol schedule of assessments.
*   Maintained source documentation and subject binders following ALCOA+ principles and ICH-GCP guidelines.
*   Actively monitored and reported adverse events/SAEs in alignment with protocol and regulatory requirements, demonstrating
*   commitment to participant safety.
*   Developed and implemented department-specific SOPs, reducing errors and deviations, and safeguarding patient safety and confidentiality.
*   Assisted in routine monitoring visits and internal audits, aiding in the resolution of any issues in a timely manner.
*   Created case report forms, ensuring the collection of all required information at each study visit and that protocol is followed.
*   Performed drug accountability for subject visits and sent prescriptions to investigational pharmacy.
*   Entered data into EDC and resolved queries in a timely manner.
*   Processed laboratory samples following instructions set forth in protocol lab manuals and shipped biological specimens at specified intervals.
*   Trained and provided helpful tools/instructions to new clinical research coordinators.

Elizabeth Miller

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