Misty Moore Email & Phone Number

Nashville, Tn, Us

Manage performance and professional development of study operations staff.Create, monitor, document and follow departmental SOPs, WPGs and corporate guidelines.lan and track all clinical trial activity assigned to the department, including startup, enrollmentand closeout.Develop status reports based on team metrics and communicate to leadership.Review proposed clinical trial budgets and protocols; assess feasibility and data requirementsprior to initiation as well as on an ongoing basis.Review all clinical trial contracts to determine data deadline parameters.Ensure timely and accurate entry of data into assigned databases.Ensure, review and approve source documentation as required.Assist in slot management of applicable studies for monthly enrollment to ensure appropriateclinical trials are prioritized and accrued.Build and maintain strong industry sponsor and internal team relationships to ensure effectivecommunication.Prepare ad hoc reports for leadership, sponsor, CROs and other individuals/groups as needed.Receive and triage information requests; research and provide information where appropriate.Maintain positive and cooperative relationships in day-to-day interactions and communications.Promote effective teamwork among Study Coordinators and Data Coordinators.Communicate and escalate unresolved issues at the appropriate time and to the appropriatelevel of leadership.Attend and participate in assigned Sponsor meetings as well as internal leadership and teammeetingsAttend meetings with Principal Investigators to provide updates and support for ongoing clinical trialsParticipate in educational activities and programs.Maintain strictest confidentiality.Ensure all staff adheres to professional standards, good clinical practice (GCP) and SOPsestablished for clinical research.

Leads a team of Clinical Trial Managers and /or Data Coordinators and reports issues/concernsto Data Operations Manager. Communicates and escalates unresolved issues at the appropriate time to the appropriate level of managementKeeps management abreast of issues and progress on all assigned projects and the projects ofteam membersReports metrics on all assigned projects and the projects of team membersResponsible for ensuring the integrity of data and providing recommendations for correctiveaction when necessaryMeets with physician lead to provide necessary updatesLeads the execution of highly complex trials for the research team. Trials assigned will involvecomplex monitoring, data entry and/or high volume of enrollmentResponsible for training, education and mentoring Clinical Trial Manager I, Clinical Trial ManagerII and Data Coordinators; mentors and coaches new and /or junior data management staffReview and approval of source document forms for implementationProvide back-up support and data entry assistance as needed for team membersInitiate improvements, tools, processes, and forms to enhance the efficiency and the quality ofwork of Phase 2/3 Data Operations Confirm patient eligibility and discuss discrepancies with nursing staff and physiciansVerify screening procedures are performed within the protocol specified windowMonitor patient toxicity on trial according to Common Toxicity Criteria, including adding data tologs from source, confirming grades assigned by nursing staff, and ensuring consistency of dataPlanning and tracking of all assigned clinical activity in the lifecycle phases of the start up,interim and close outEducates Research Nurses on protocol modifications and specifications including visit schedule,assessment windows, dose modifications, central and local laboratory assessmentsCreates study specific tools for source documentation.

Greater Nashville Area, Tn

Plan the execution and monitor the completion of more intense andcomplex Phase I-IV assigned clinical research protocols. Including abstracting, assembling andorganizing research data while monitoring adherence to the clinical protocol and preparing reports onthe data. Will work closely with the physician principal investigator, manager of data operations, clinicaltrial sponsor and study team.Duties include but are not limited to: Leads the execution of highly complex trials for the research team. Trials assigned will involve complex monitoring, data entry and/or high volume of enrollmentAssist with the training of new Clinical Trial Managers and Data Coordinators. Responsible for mentoring Clinical Trial Manager I and Data Coordinators. nitiate improvements, tools, processes, and forms to enhance the efficiency and the quality of work of Phase 2/3 Data Operations. Confirm patient eligibility and discuss discrepancies with nursing staff and physicians. Verify screening procedures are performed within the protocol specified window. Monitor patient toxicity on trial according to Common Toxicity Criteria, including adding data to logs from source, confirming grades assigned by nursing staff, and ensuring consistency of dataacross the medical record. Educates Research Nurses on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments. Creates study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable)

Ensure that clinical trials are conducted in accordance with State and Federal regulations, Good Clinical Practice regulations, and standard operating proceduresFacilitate site visits including pre-study, study initiation, routine monitoring, study closeout, and sponsor site auditsEnsure that all study patients are consented appropriatelyReport serious adverse eventsMonitor patient response to current therapy and assure patient safetyEnsure that case report forms are completed in a timely manner and submitted per sponsor requirementsRegularly report study progress to the Principal Investigator, including detailed patient status, serious adverse events, toxicities, protocol deviations, study-wide updates, etcEducate and support physician investigators and research staff so that they may practice adherence to protocol requirements and specificationsProvide continuous support and excellent customer service to physician investigators and research nurses to ensure patient safety and protocol complianceDisseminate protocol amendment specifications and other study related updates to clinical research team in a timely mannerEnsure study timelines are met, study progress is reported appropriately and tracked, and maintain study status within SCRI clinical trial tracking databases