Ray Mo Email & Phone Number

United States

Brea, California, Us

Oversight/execution of feasibility, selection ,setup, conduct and closure of a clinical trial within the allocated countries ,in accordance with ICH-GCP,applicable SOP ,Perform remote and on-site monitoring & oversight activities using various tools to ensure data generated at the site are complete, accurate and unbiased.Ensure subject’s right, safety, and well-being are protected.Maintains up to date and accurate tracking on the monitoring status for each site in applicable systems for the study .Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits. Records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.Collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.Identify assess and resolve site performance, quality or compliance problems and escalate per defined Clinical Research Associate (CRA) Escalation Pathway as appropriate. •Manage and maintain information and documentation in the Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and various other systems as appropriate and per timelines.Contribute strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.Support and/or lead audit/inspection activities as needed.Ensures subject specific data accuracy through source data review ,source data verification and care report form.Review and verify data via onsite/remote monitoring visits.in accordance with the approved monitoring plan and e CRF completion guidelines.

Princeton, New Jersey, Us

• Responsible for monitoring all stages of the conduct of clinical trials in assigned study site. This Include performing study Site Selection Visit, Site Initiation Visit, Routine Monitoring Visit and Close-out Visits according to company SOPs. • Conducted PSSV, SIV, IMV and COVs at assigned clinical sites and generated visit/contact reports. • Ensured all trip reports were completed to quality standards within company specified timelines. • Maintained required documentation in the investigator site file and provided required documentation for the Trial Master File. • Ensured that assigned trial site complied with the study protocol, GCP, and applicable regulatory requirement for performing study activities, regarding the implementation and monitoring of clinical trials, to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs. • Managed investigational product supplies to trial site. Kept track of drug lots/batches and expiration dates, and assisted in investigational product forecasting in accordance with study agreements. • Performed on-site drug accountability and reconciliation, and verified drug storage met protocol and SOP requirements. • Verified patient eligibility, communicated and documented protocol violations, non-compliance, and poor performance and ensured that corrective action were taken. • Performed ongoing reviews of Investigator’s Trial File to assure quality of the documentation files, completion and compliance with company SOPs, GCP and ICH Guidelines while on site. • Completed follow up letters for all visit types according to SOPs. • Liaised with other CRAs to ensure the harmony of standards and procedures. • Acted as primary liaison for assigned study sites while on-site to convey project information, answer questions and address study issues in accordance with the monitoring plan.

Princeton, New Jersey, Us

• Verified patient eligibility, communicated and documented protocol violations, non-compliance, and poor performance and ensured that corrective action were taken. • Performed ongoing review of Investigator’s Trial File to assure quality of the documentation files, completion and compliance with company SOPs, GCP and ICH Guidelines while on site. • Completed follow up letters for all visit types according to SOPs and completed reports to quality standards within company specified timelines. • Acted as primary liaison for assigned study sites while on-site to convey project information, answer questions and address study issues in accordance with the monitoring plan. • Conducted PSSV, SIV, IMV and COVs at assigned clinical sites and generated visit/contact reports. • Served as the main contact for assigned study sites. • Ensured adherence to study protocols, company’s SOPs, and compliance with GCP guidelines and FDA regulations and IRB requirements. • Reviewed source documentation, case report forms, and data reports for accuracy, completeness, and timely submission. • Managed investigational product accountability. • Communicated and worked with site investigators and research staff to ensure proper reporting of adverse events and ensured protocol deviations were escalated to manager promptly. • Collected and transferred required site documents for trial master file. • Participated in development of clinical study materials, such as source documentation, work instructions, patient recruitment materials and product training. • Attended relevant scientific meetings as directed. • Provided site updates at study team meetings.

• Responsible for conducting site visits (initiation, monitoring, and termination) to the assigned investigational sites to ensure that study is being conducted according to the protocol, project plan, ICH GCPs, and FDA regulations. • Ensured sites were adhering to the FDA and ICH-GCP regulations and that new study updates and guidelines were implemented as required. • Ensured adherence to local regulations and company SOPs. • Ensured the completion and collection of regulatory documents. • Evaluated and reported site performance and protocol compliance. • Conducted PSSV, SIV, IMV and COVs at assigned clinical sites and generated visit/contact reports. • Performed data verification of source documents and ensured that CRFs were consistent with source and accurately completed. • Verified that written informed consent were obtained before each subject’s participation in the trial. • Performed investigational product accountability and tracked IP supply to ensure that site had adequate drugs for the study conduct. • Ensured completion and collection of SAEs and that they were being reported to the sponsor and IRB in a timely fashion. • Ensured that the PI was reviewing IND Safety Alerts and that they were being reported to the IRB as required. • Assisted with data validation and resolution of queries. • Completed visit reports and sent both pre-visit and post-visit communication to site in a timely manner. • Completed all administrative tasks (Such as calendar updates, expense reports, timesheets, etc.) in a timely manner.

Houston, Tx, Us

• Implemented subject recruitment strategy in conjunction with the Principal Investigator prior to study start up. • Recruited and screened potential study subjects according to the protocol’s inclusion and exclusion criteria. • Obtained proper informed consent, from each study subject prior to participation in the study. • Adequately ensured each trial conducted within the company was according to study specific protocol. • Reviewed and resolved all Interim Monitoring Reports and findings. • Oversaw overall clinical operations related to the conduct of the trial (i.e. recruitment, visit coordination, sampling, visit scheduling, etc.) • Worked in collaboration with study team and QA Manager to ensure trial preparation and coordination. • Maintained certification of GCP along with any protocol specific required training. • Ensured that IRB approval was obtained prior to study initiation and that the IRB requirements were met throughout the duration of the study. • Collected, organized and submitted all required regulatory documents at study start up in a timely, accurate manner. • Reported all adverse events to the Investigator and Serious Adverse Events to the Principal Investigator, Center Manager, and Sponsor immediately. • Maintained adequate and accurate source documentation for each study subject that recorded all observations and data during the study. • Completed the Case Report Form/EDC for the study accurately, completely, and in a timely manner.