Experience

Unison Clinical Trials

• United States
• Medical Practices
• 1 - 100 Employee

• Clinical Research Site Manager at Unison Clinical Trials

  • Jun 2022 - Present

  Los Angeles Metropolitan Area

• Senior Clinical Research Coordinator

  • Nov 2019 - Jun 2022

  Sherman Oaks, California Interpreted regulatory rules or rule changes and monitored communication through corporate policies and procedures. Prepared and submitted regulatory file applications and supporting documentation. Study startup, regulatory, IRB and any other associated submissions, including but not limited to 1572s, Financial Disclosure agreements, as well as review and provide necessary feedback on CTA(s) and/or study budget(s) to Principal Investigator Kept up-to-date with changes in regulatory… Show more Interpreted regulatory rules or rule changes and monitored communication through corporate policies and procedures. Prepared and submitted regulatory file applications and supporting documentation. Study startup, regulatory, IRB and any other associated submissions, including but not limited to 1572s, Financial Disclosure agreements, as well as review and provide necessary feedback on CTA(s) and/or study budget(s) to Principal Investigator Kept up-to-date with changes in regulatory legislation and guidelines and obtained marketing permissions. Recommended improvements to processes. Prioritized project-related tasks to efficiently complete essential tasks. Managed team of employees, overseeing hiring, training and professional growth of employees. Maintained, ensured and archived regulatory paperwork. Conducted clinical Phase IB - IV trials in Endocrinology, Dermatology, Gastroenterology and Neurology Collected data on research progress, adverse reactions, deviations and results Collected data and followed research protocols, operations manuals and case report form requirements. Gathered, evaluated, organized, managed and collated information in varying formats. Maintained trial policy records and procedure materials Monitored all site SOPs and Source/CRFs for accuracy Supervised data collection by core research staff. Outreach within centralized research databases for potential new studies Maintained compliance with protocols covering patient care and clinical trial operations. Screened patient records, databases and physician referrals to identify prospective candidates for research studies. Monitored unit budget to meet financial objectives for spend rate and funding. Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting. Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets. Identified issues, analyzed information and provided solutions to problems.



Alta California Medical Group

• United States
• Government Relations Services
• 1 - 100 Employee

• Clinical Research Study Coordinator

  • Apr 2015 - Jan 2020

  Simi Valley, CA Conducted clinical Phase II - IV trials in Diabetes, Infectious Diseases, Women's Health, Neurology and Vaccines studies Collected, evaluated and modeled collected data for up to 10 clinical research studies at any given time Updated case reports and source documents for clinical trials, arranged study interviews and recruitment Updated medical records, maintained information on protocol and case reports of each trial, developed flow sheets and identified subject… Show more Conducted clinical Phase II - IV trials in Diabetes, Infectious Diseases, Women's Health, Neurology and Vaccines studies Collected, evaluated and modeled collected data for up to 10 clinical research studies at any given time Updated case reports and source documents for clinical trials, arranged study interviews and recruitment Updated medical records, maintained information on protocol and case reports of each trial, developed flow sheets and identified subject eligibility Performed QA/QC procedures, worksheets and study materials, collected data and ordered supplies Prepared consent amendments and processed specimens Screened patient records, databases and physician referrals to identify prospective candidates for research studies. Collected data and followed research protocols, operations manuals and case report form requirements. Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols. Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets. Prepared variety of different written communications, reports and documents. Developed team communications and information for meetings. Maintained energy and enthusiasm in fast-paced environment. Prepared sponsor files for FDA compliance and GCP guidelines Collaborated to create IRB submissions, revisions and consent material Collected data on research progress, adverse reactions, deviations and results Ensured regulatory compliance Show less



Diagnostic Laboratories & Radiology

• United States
• Wellness and Fitness Services
• 200 - 300 Employee

• Quality Assurance Coordinator

  • Oct 2014 - Apr 2015

  Burbank Investigate and forward all laboratory issues brought forth by Internal, and Laboratory Operation departments, to appropriate department for investigation and resolution Assist management in confirming all occurrences are handled as stated, per Disciplinary Action standards Evaluated accuracy of existing quality assurance measurement techniques, implementing improvements to increase efficacy and reduce errors. Drafted reports on quality verification activity outcomes, presenting… Show more Investigate and forward all laboratory issues brought forth by Internal, and Laboratory Operation departments, to appropriate department for investigation and resolution Assist management in confirming all occurrences are handled as stated, per Disciplinary Action standards Evaluated accuracy of existing quality assurance measurement techniques, implementing improvements to increase efficacy and reduce errors. Drafted reports on quality verification activity outcomes, presenting findings to decision-makers and recommending response efforts. Addressed non-conformance issues, pausing production to correct errors. File all Corrective Actions and In-services for each individual Laboratory employee, as needed Track and monitor all licenses needed, e.g., MTA, CPT, CAP, CLIA, etc. Receive, prepare and track receipt of all CAP survey specimens to ensure proper handling, as stated per CAP guidelines Maintain all legal documents, as well as prepare any documents that may be requested, subpoenas, CMS209, etc. Create files and reports via Microsoft Excel, Weekly Occurrence reports for multiple sister labs, etc. Manage Monthly Laboratory Error report for Laboratory Director Investigated recurring customer complaints, determining source CLIA non-conformance incidences and recommending solutions. Recorded findings of inspection process, collaborating with quality team to implement corrective actions. Create External Report documents, as requested by Territory mangers, for documentation at our Facilities/Clients Perform Daily Lab QC of Instrumentation logs, Personnel Logs, etc.

• Triage - Lab Assistant

  • Sep 2013 - Oct 2014

  Burbank, CA Troubleshoot laboratory issues brought forth by other company departments, including, but not limited to liaison dept., customer service, data entry, QA Process add-on requests for in-house specimens Handle any Public Health department requests', including, but not limited to Reportable diseases, Lab reports, ship specimens per request to local Health department lab Monitor RTF for Priority accounts, satellite laboratories, any overall all specimens entering Burbank laboratory to… Show more Troubleshoot laboratory issues brought forth by other company departments, including, but not limited to liaison dept., customer service, data entry, QA Process add-on requests for in-house specimens Handle any Public Health department requests', including, but not limited to Reportable diseases, Lab reports, ship specimens per request to local Health department lab Monitor RTF for Priority accounts, satellite laboratories, any overall all specimens entering Burbank laboratory to ensure timely turnaround times Assist Customer Service department in any queries, concerns or specimen tracking for turnaround times Assist other lab department when needed to ensure timely results, i.e heavy workflow, short staff, etc. Monitor all Redraw specimens entering laboratory to ensure result are provided Assist Medical Director with any requests, i.e. Problem resolution, patient Delta checks, monitor pending issues, etc. Collaborated with management to provide training on improved processes and assisted with creation and maintenance of quality training. Collected and analyzed data and initiated improvements to increase security and performance. Developed educational materials used to train staff on QA standards



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Study Recruiter (Per Diem)

  • Apr 2011 - Dec 2011

  Glendale, CA Screened patient records, databases and physician referrals to identify prospective candidates for research studies. Perform pre-screening procedures and schedule Established, performed and managed research site's recruitment metrics Scheduled appointments with test subjects over phone and through email. Followed informed consent processes and maintained records. Meet, greet and perform outreach at local health fairs, Mental health facilities, etc. to gather data for company… Show more Screened patient records, databases and physician referrals to identify prospective candidates for research studies. Perform pre-screening procedures and schedule Established, performed and managed research site's recruitment metrics Scheduled appointments with test subjects over phone and through email. Followed informed consent processes and maintained records. Meet, greet and perform outreach at local health fairs, Mental health facilities, etc. to gather data for company database to aide in recruitment Contact patients in database update information, as needed Show less



Q² Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• CRC - Representative II

  • Apr 2004 - Apr 2011

  Northridge, CA As a Quest Clinical Trials CRC Rep II, I performed the following duties: ▪ Perform outgoing calls to study sites to retrieve missing patient information or sample collection information ▪ Call study sites to notify study nurses or investigators of Critical and priority lab values, test cancellations, test(s) not performed and send faxes as requested ▪ Answer multiple calls from call center queue ▪ Direct callers to appropriate extension and departments or lab… Show more As a Quest Clinical Trials CRC Rep II, I performed the following duties: ▪ Perform outgoing calls to study sites to retrieve missing patient information or sample collection information ▪ Call study sites to notify study nurses or investigators of Critical and priority lab values, test cancellations, test(s) not performed and send faxes as requested ▪ Answer multiple calls from call center queue ▪ Direct callers to appropriate extension and departments or lab personnel ▪ Email, fax and call International study sites of important study information ▪ File any important information entering the laboratory, including patient demographics, study site information, and Pharmaceutical contact regarding the study ■ Attend daily Laboratory Operations meeting ■ Provide client with proper assistance in performing laboratory procedures, such as intravenous blood collection, proper tubes, and any required materials, etc. ■ Assist client in understanding Lab manual for study specific blood collections ■ Train new employees on Client Services processes, Incoming call queue, outgoing, holds, etc. ■ Q.C. Client Tele log ■ Daily use of Microsoft Outlook to communicate with external and internal clients ■ Perform basic office duties e.g. faxing, copying, filing, emailing internal and external clients ■ Perform specific pharmaceutical requests, special reporting of lab alerts ■ Email and call pharmaceutical contacts to report or retrieve specific study information ■ Work with management and leadership team in establishing new standards/procedures (Gold Standards) for client/customer satisfaction Show less