Miley Lott

• Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
• Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
• Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
• Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
• Observed clinical studies and assessed health outcomes in groups of participants to support research plan.
• Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
• Conducted clinical trial in accordance with protocol and recorded and monitored progress.
• Processed specimens for clinical trials, sample storage and assay to provide registry of samples for test development, validation and analysis.

Job Duties

• Responsible for inputting large amounts of medical data entry with weekly deadlines and reporting
• Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
• Implemented electronic data capturing systems to adhere with clinical research guidelines.
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
• Manual Data and Query Management
• Assisted in Start-Up Activities: Research and Development COVID-19 ISPY Trial
• Monitoring in platform design COVID-19 trial with QLHC
• Demonstrated leadership skills in managing projects from concept to completion
• Cultivated interpersonal skills by building positive relationships with others
• Completed paperwork, recognizing discrepancies and promptly addressing for resolution
• Passionate about learning and committed to continual improvement
• Demonstrated creativity and resourcefulness through the development of innovative solutions

Job Duties

• Responsible for inputting large amounts of medical data entry with weekly deadlines and reporting
• Track subject enrollment and identify R&R issues, maintain regular communication w/site staff.
• Management of over 20+ studies (Blinded and Unblinded Capacity)
• Conducting average of 15 DOS throughout my experience with DOCS
• Document and communicate study site progress and issues/concerns to project team.
• Assist other CRAs with study site issues/concerns/audits
• Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues
• Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality
• Supported development and delivery of department training to maximize success of clinical research
• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion

Job Duties

• Responsible for inputting large amounts of medical data entry with weekly deadlines and reporting
• Clinical Trial Monitoring/ Management under Risk-Based Monitoring Model
• Perform as a lead monitor responsible for full SDV, SDR, CRF, and regulatory management and review
• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• Responsible for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Responsible for all aspects of site management as prescribed in the project plans

Job Duties

• Responsible for inputting large amounts of medical data entry with weekly deadlines and reporting
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
• Responsible for all aspects of site management as prescribed in the project plans
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

Job Duties

• Responsible for inputting large amounts of medical data entry (patient and research) with weekly deadlines and reporting
• Overall management of multiple clinical trials (Twelve GI/Hepatology, Phase IIa-III). I am a liaison between the sponsor, the principal investigator, and the site. I pre-screen, conduct all four types of visits, provide informed consent, and facilitate follow up appointments with patients, and keep clear communication between all three parties above
• CTCAE reporting for Adverse Events
• Assembly, review, and maintenance of both the regulatory and patient/subject binder for each clinical study including essential documentation in compliance with IRB, GCP/FDA, and Sponsor standards
• Collect and maintain clinical data during all phases of the specimen procurement, case reporting in electronic data capture systems
• Process, Store, and Shipment of solid and liquid tissue specimen according to SOP & IATA standards

Job Duties

• Responsible for inputting large amounts of medical data entry (patient and research) with weekly deadlines and reporting
• Overall management of numerous clinical trials (Ten Oncological Studies, Phase IIa-III). I am a liaison between the sponsor, the principal investigator, and the site. I pre-screen, conduct all four types of visits, provide informed consent, and facilitate follow up appointments with patients, and keep clear communication between all three parties above
• Cancer Therapy Evaluation under RESIST Guidelines
• Assembly, review, and maintenance of both the regulatory and patient/subject binder for each clinical study including essential documentation in compliance with IRB, GCP/FDA, and Sponsor standards
• CTCAE reporting and documentation of adverse Events
• Collect and maintain clinical data during all phases of the specimen procurement, case reporting in electronic data capture systems
• Process, Store, and Shipment of solid and liquid tissue specimen according to SOP & IATA standards
• Training of new team members in SOP daily operations, patient informed consenting, screening, lab maintenance, data management, and tissue processes
• Collected data and followed research protocols, operations manuals, and case report form requirements
• Prepared and maintained regulatory documents for clinical trial submissions
• Monitored patient safety throughout clinical trials and reported any adverse events
• Developed and maintained accurate and up-to-date case report forms and source documents
• Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations
• Collected, evaluated, and modeled collected data
• Managed patient recruitment, informed consent process and data entry to support trial objectives

Job Duties

• Responsible for inputting large amounts of medical data entry (patient and research) with weekly deadlines and reporting
• A project regarding the behavioral and morphological classification of drug resistance in particular breast cancer cells.
• Worked in understanding resistance mechanism(s), to prevent the continued growth of cancer and effectively treat patients with drug-resistant breast cancer.
• Conducted literature searches on the particular drug-resistant breast cancer cell line to gather information on previous industry facilitated trials.
• Learned about cancer cells and various methods used to classify cancer cells given the type of cancer, methods of testing for cancer, and mammalian cell culture techniques used to maintain established cancer cell lines.
• Implemented, Executed, and Recorded experiments to test each attribute in the classification of breast cancer cell type.
• Introduced to regulatory aspects of clinical care and research: HIPAA, ICH GCP, FDA (Title 21)

Job Duties

• Responsible for inputting large amounts of medical data entry (patient and research) with weekly deadlines and reporting
• Organized experiments laboratory lectures for various Biology course: Endocrinology, Cellular Biology, Neurology.
• Coordinated laboratory organization in equipment/supplies via logging and stocking, and working collaboratively with staff and lab professors.
• Utilized in-depth grasp of Biology and Chemistry studies to better able assist in the preparation of laboratory lectures.
• Maintained strict aseptic fields when collecting biological samples, minimizing staff and patient infection risks.
• Prepared, embedded, cut, stained, mounted, labeled and catalogued tissue sections

Major: Biology (concentration: Cancer Biology); Minor: Business

Accomplishments

• Presented findings to research mentor, staff, and peers at Loyola's Undergraduate Research Colloquium as well as the Georgetown's Undergraduate Research Colloquium
• Attended the American Association for Cancer Research to remain aware of current research happenings in cancer and become involved in discussions on how to improve cancer research in years to come