Estee Mo Email & Phone Number

United States

• Identify, evaluate, and establish clinical study sites.• Conduct regular site monitoring visits (virtually and physically) and prepare reports for study initiation, monitoring, and close-out visits.• Draft and/or provide input into Clinical Study Protocols, supporting plans, and procedures, including Informed Consent Forms (ICFs), Monitoring Plans, and Data Collection Forms in conjunction with the assigned Project Team.• Assist with Institutional Review Board (IRB) submissions.• Manage study budget and agreements with study sites.• Manage study Trial Master Files.• Train site staff on protocol requirements, source documentation, and case report form completion.• Serve as point of contact with study sites during IVD medical device studies.• Attending regularly scheduled teleconference meetings with clients during study preparation and throughout studies.• Monitor and analyze clinical study data and report on performance both internally and with study sponsors.• Assist with the development of study databases for managing clinical data.

• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites• Reviews and verifies the accuracy of clinical trial data collected, either onsite or remotely.• Performs essential document site file reconciliation.• Performs source document verification and query resolution.• Assesses IP accountability, dispensation, and compliance at the investigative sites.• Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines.• Communicates with investigative sites.• Updates applicable tracking systems Ensures all required training is completed and documented.• Facilitates audits and audit resolution.• Ensures all required training is completed and documented.

• Performed site selection, initiation, interim monitoring, and close-out visits in accordance with contracted scope of work and good clinical practice.• Provided monitoring visits and site management for a variety of protocols, sites, and therapeutic areas.• Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Lead (CL) and/or site and resource manager.• Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Created and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports and other required study documentation.• Helped less experienced clinical staff.

• Assisted project teams with trial progress tracking by updating the Clinical Trial Management Systems.• Contacted clinical sites for specific requests for enrollment updates, missing documentation, meeting arrangements, and so on.• Assisted in the tracking and distribution of safety reports. • Supported the Clinical Operations teams with ongoing conduct of studies.• Assisted project teams with study-specific documentation and guidelines as appropriate.• Assisted with routine data analysis and interpretation using data analysis programs.• Assisted in the setup, operation, and maintenance of research equipment/instruments.• Helped clinic staff by organizing files, projects, data, etc.• Provided general office management to keep operations running smoothly.• Assisted with the development and execution of clinical research studies and programs.