Eva Hampton Email & Phone Number

Memphis, Tn, Us

Memphis, Tn, Us

Memphis, Tennessee, United States

Greater Memphis Area

Responsible for the monitoring activities of Phase I, II, III and IND St. Jude initiated clinical trials and external sponsored clinical trials by conducting pre-study, site initiation, interim monitoring, and close-out visits in compliance with FDA regulations, ICH guidelines, Good Clinical Practice (GCP), SOPs, Data and Safety Monitoring Plan, and other applicable regulatory requirements at St. Jude and collaborating sites. Verify data accuracy/completeness, adverse event reporting, and protocol compliance by comparing protocol document with source documents, and ensuring that the conduct of the trial is in compliance with currently approved protocol and applicable regulatory requirements.Monitor regulatory documents to ensure compliance with SOPs, GCPs, IRB review, and applicable regulatory requirements.Coordinate collaborating sites monitoring visits, which include completing necessary administrative tasks (i.e. travel authorization and expense reporting). Develop moderate risk monitoring plans according to the St. Jude Institutional Data and Safety Monitoring Plan. Troubleshoot and resolve study team and site-related issues and communicate protocol deviations, data quality problems and site performance issues to Monitoring Management Team.Prepare detailed monitoring reports and follow-up letters within a timely manner to document findings of monitoring visits and discussions with site.Maintain study specific monitoring files and manage/track monitoring processes in the institutional monitoring database (CASPIO).Ensure study drug accountability for Phase I clinical trials. Act as resource for team members and assist with the training of new monitors. Participate in working groups to revise and develop monitoring tools. Responsible for performing monitoring activities for assigned protocols in the following disease service areas: Oncology, Transplant and Gene Therapy, Infectious Diseases, and Hematology.I also have auditing experience.

Memphis,Tn

• Provides management of clinical research protocol operations and review efforts of the Central Protocol and Data Monitoring Office. - Manages clinical research staff responsible for protocol development and activation, participant enrollment and eligibility verification, and coordination of the Scientific Review Committee.- Ensures that protocol development is conducted according to institutional standards, that all appropriate research documentation has been obtained, and that research participant eligibility verification follows the institutional Data and Safety Monitoring Plan. - Maintains familiarity with clinical research studies and procedures in all clinical research areas, both therapeutic and non-therapeutic.- Serves as Administrative Director of the Clinical Trials Scientific Review Committee.•Provides direct oversight and leadership of primary office functions.- Works closely with Principal Investigators, Directors of Clinical Trials, Research Coordinators, and Clinical Research Associates in the development and maintenance of clinical research trials.- Works closely with other administrative or support offices, such as Clinical Research Education, Clinical Research Shared Resources, Office of Human Subjects Protection, and Regulatory Affairs.• Project management of department initiatives• Provides management of Protocol Operations personnel• Provides education and training

Memphis, Tn

• Assists the clinical staff in the development, initiation and submission of protocol and informed consent documents throughout SJCRH and it’s affiliates• Serves as primary resource to clinical investigators in the development of clinical research protocols• Review and edit protocols during development, working closely with the Principal Investigator (PI), Clinical Research Monitor, Research Coordinator, and Research Studies Pharmacist• Prepares and/or edits informed consent statements and protocol eligibility checklists• Prepares and/or amendments and revisions• Reviews all Scienctific Review Committee and Internal Reviw Board submissions prior to review by those committees• Tracks protocol and consent development, submission and approval; monitors submissions and ensures that the documents are resubmitted for final review and approval• Assures protocol compliance to standard institutional format and meets requirements of the institutional review and monitoring boards and external regulatory agencies• Maintains all current and historical information for the Institution's clinical research protocols• Prepare and activate IRB approved protocol and consent documents for Institutional use• Trains new Clinical Investigators and research team members in protocol and consent development procedures• Tracks status of all IRB approved protocols• Prepare monthly reports and enter all protocol information into the institutional enrollment database• Coordinate and administer activity related to the DocuShare Intranet document sharing system for the institution• Design and update schemas and roadmaps to accompany research protocols

Masters, Health Administration

Certificate, Medical Technology

Bachelors, Biology

Activities and Societies: JSU Honors Division, Beta Beta Beta Biological Society, Minority Biomedical Research Program, Delta Sigma Theta.