San Antonio, Texas, United States
• Conduct In-house Monitoring of other site coordinator’s source documents, CRFs, ICFs, etc to preprae for Sponsor and/or FDA audits. • Strategically plans and meets with potential sponsors at Pre-Site(Site Qualification) meetings. • Certify that ALL regulatory documents are submitted to the IRB and sponsor in a prompt manner. • Maintains regulatory binder including the 1572, Protocol, IB, ICF, FDF, CVs, Licenses, IRB approved study documents, Patient recruitment materials, Laboratory ref. ranges, Lab personnel credentials, CLIA/CAP certifications, Central laboratory credentials, IATA certificates, Protocol training and study site delegation logs, Laboratory processing manual. • Attends Investigator meetings with Investigators and facilitates SIVs with sponsor representatives and documents issues requiring clarification. • Provide weekly updated pre-screen and screening logs to Sponsor, and attend conference calls to further update CRA and sponsor. • Screen subjects, complete the ICF process, draw lab specimens, obtain vital signs, complete ECGs and specimen processing portion of screening visits. • Maintain strict ICH/GCP clinical trial guidelines at every step of the clinical trial process. • Ensure that subjects adhere to all study visits. • Meet with CRA at scheduled date and times for monitoring visits. Review monitor reports with CRA, and complete/correct all deficiencies in the reports. Discuss any protocol deviations with CRA, report these to the site’s IRB, and Implement a corrective action plan to prevent future deviations. • Input study visit CRFs in the EDC system according to the sponsor-site contracted time frame, while verifying that the EDC system is an exact reflection of the site source documents. • Report any AEs and SAEs to the sponsor and IRB within specified time frames. • Complete close out visit with CRA as well as IRB and send back or destroy all study medications and remaining study kits in accordance with sponsor guidelines.
• Supervise and care for the specialized Biophotonics Advanced Imaging & Analysis Laboratory. • Oversee the use and repair of the laboratory’s microscopes and projects, under the supervision of the director. • Collaborate with Principal Investigators in development of study imaging protocols and monitor data. • Provide guidance to all grad students, post docs, and PhD’s to use the multi-photon, the confocal fluorescence, and the live cell incubation microscopes. (Zeiss 510 & 710) • Assist grad students, post docs, and PhD’s in the use of laboratory’s imaging technology, in order to conform to study protocols and lab SOPs • Instruct lab personnel on proper utilization of imaging and analysis software to process data collected from the microscopes for publication purposes. • Organize and Facilitate workshops that take place in the Advanced Imaging & Analysis lab. • Assist in website maintenance and operation for the imaging lab.
• Independently Ran and supervised an offsite laboratory in Houston, Texas. • Perform onsite Micro- ELISA's, serum enzymatic endpoint type chemistries, enzymatic urinalysis, and advanced coagulation testing. • Created and perfected existing Standard Operating Procedures (SOP’s) to fit the companies growing testing needs. • Conducted quality control, maintenance, and proficiency testing to maintain compliance with CLIA. • Developed an interactive Microsoft Excel spreadsheet, for my lab, that was later adopted by the entire company to meet the needs of heavy patient volumes and high doctor demands. • Used careful planning and time management to facilitate great outcomes from myself as well as others in the laboratory in areas such as: Patient handling, Patient Privacy, Lab cleanliness, accurate testing, and data report results. • Effective multi-tasker able to coordinate the development of long term or daily projects, tasks and goals.