Seeking a position in Clinical Research with a globally focused organization, this will utilize my qualifications, while offering new opportunities to integrate personal enrichment and professional goals.
Participated in global study meetings with Oncology sites and sponsors.
Worked closely with Program Manager and Director on protocols Management of SAE s , SAE Safety Review, and Investigator Safety Letters Interface with physicians and study support personnel.
Served as Primary Liaison between Oncology sites and sponsor Coordinated with sponsor for all Oncology project deliverables within timeframe Reviewed & monitored regulatory documents according to ICH/GCP guidelines and 21CFR and ensured SOP, FDA, ICH, GCP compliance Responsible for all phases of clinical trials, from feasibilities through to start-up, monitoring and close-out Evaluated work for clinical projects.
ex: monitoring reports, EDC data etc) Conduct pre-investigational site visits and staff in-service.
Maintain contact and support during study.
CNS NetworkGarden Grove, CASenior Clinical Research Coordinator
Primary Study Coordinator for the research site on 9 protocols simultaneously, ensured the implementation of all study procedures per protocol assigned, and served as regulatory coordinator on all assigned protocols.
Submission of SAE's, Safety Reports, Protocol Deviation, Temperature excursion, IRB acknowledgment, and most required IRB forms.
Coordination and implementation of protocols in compliance with GCP and ICH Guidelines, assisted in drafting documents for several protocols, drafting of enrollment logs and study medication logs for various protocols at site, and also responsible for IVRS, EDC for 8-10 protocols.
Ensured the safety of study patients by following protocol and safety measures, liaison between site, CRA and vendors.
Responsible for oversight of all staff assigned to the 9 protocols.
Monitored project activity and managed the project group.
Diabetes/ Lipid Management & Research CenterHuntington Beach, CASenior Clinical Research Coordinator
Primary Study Coordinator and regulatory coordinator for the research site on 7 protocol, and ensured the implementation of all study procedures per protocol assigned.
Review of AE, SAE and concomitant medications.
Primary laboratory specialist for all protocols on site (15-20 protocols).
Responsible for management of clinical operations of site.
Management of all regulatory documents and submissions.
IRB, Conducted and managed several medical device studies.
CRF, Patient Training, Data Collection etc.) Management of all data, EDC, IVRS etc Assist in the development of data collection forms, clinical site study material, and clinical databases.
Best of Times ADHCLos Angeles, CASocial Workers Assistant
Patient Assessment such as mental assessments, psychological tests, and questions, projects such as coordinating day events for participants, creating group therapy sessions 1-3 times a week for participants, and conducting group counseling for patients 2-3 times a week.
Maintained regulatory documents for project manager, responsible for organization of participant charts, overseeing patient's growth in the program and help participants grow mentally.
Diabetes Research CenterTustin, CAClinical Research Assistant
Assisted with study procedures.
Administrative office functions.
Assisting with various clinical study projects.
Assigned daily projects by the director of ophthalmology (Harold Jensen) as well as work on projects with the director of ophthalmology.
Track files and folders for CRA's review, FDA regulation guidelines with CRA's, reviewing SAE's and AE's with CRA's, help organize payment files for CPA's,.
Attend meetings with the director of ophthalmology, Create files and charts, data entry as assigned by director or CRA, and review ECRF entries from participating sites with the CRA.
Administrative, charts, clinical study, clinical trials, Strong communication skills, counseling, CPA, data collection, data entry, databases, Diabetes, Diabetic, drafting, forms, functional, GCP, HIPAA Regulations, IND, IVRS, Letters, Director, meetings, office, Oncology, ophthalmology, Patient Training, personnel, Project Management, protocols, quality, regulatory documents, research, Safety, SOP, therapy, Type I, Type II