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Click here or scroll down to respond to this candidateCandidate's Name
Phoenix, Arizona Street Address PHONE NUMBER AVAILABLE EMAIL AVAILABLEU.S. Navy Veteran Graduate in American Indian Studies History, Magna Cum Laude Arizona State University graduate, focuses on philanthropy, ethical practice, and exceptional patient care in the medical field. With over 20 years of experience in ophthalmology, I have learned essential skills and vast knowledge within the field. Within the last 5 years, Research has become a special interest for me, and I plan to seek further education in the field of research.SkillsTeam PlayerEngaged and Focused LearnerBuilding Strong Physician RelationshipsMulti-Project Organization and ManagementCITI GCP Social and Behavioral researchPharma EngineRAVECentral LabsZelta EDCIATA certifiedGood Clinical Practice Certified (GCP)CPR CertifiedStudy coordinatorCITI GCP Clinical Trial with Investigational Drug and MedicalVeeva Vault CTMSOracle InformJUDI systemImedata EDCHIPAA Compliant for Medical SettingElectronic Medical RecordsElectronic Data Capture System Entry (EDC)Phase I-IV Trial ExperienceProtocol ComplianceCITI Biomedical ResearchFirecrestMedidataVeeva CTMSAlpha/Sterling/CIRBI IRBProfessional ExperienceCornea and Cataract Consultants of Arizona Phoenix, AZClinical Research Site Manager/ Clinical Study Coordinator (5/2023-present)IQVIA Pharmaceutical Company San Diego, CAClinical Research Associate 2 (09/2022-12/2022)Clinical Research Associate (Medasource Contracted-COMMON SPIRIT) BNI CRO Phoenix, AZClinical Research Associate (11/2021-09/2022)Clinical Research Consortium/ Allied Multispecialty Research Tempe, AZClinical Research Coordinator (11/2020 10/2021)RETINAL CONSULTANTS OF ARIZONA LTD/RETINAL RESEARCH INSTITUTE LLC Phoenix, AZClinical Research Coordinator (05/2017-11/2020) Certified Ophthalmic Assistant (1998-05/17)Cornea and Cataract Consultants of Arizona 3815 E. Bell Rd. #2500, Phoenix, AZ 85032Maintaining up-to-date regulatory documents including site start-up, and Independent Review documents, as well as obtaining and maintaining up-to-date Curriculum Vitae, MICA, and licensing for all site investigators and study staffResponsible for renewing and submitting Continuing Review form to the IRB.Training of investigators and staff not present at Investigator Meetings or Site Initiation Visit in proper study protocol and execution to ensure accuracy of data and maintenance of study blind.Initial reporting and update of Serious Adverse Events to IRB and study sponsors promptly to ensure subject safety.Processing of lab specimens for accurate Immunogenicity and Pharmacokinetic results in multiple studiesResponsible for working up study patients: collecting medical history, vision examination, intraocular pressure, manual trial refraction, external slit lamp exams, scribing, and dilation.Follow GCP and Human Subject procedures for trials in enrolling and ongoing studiesResponsible for managing the research department.IQVIA Pharmaceutical Company 10188 Telesis Ct #400, San Diego, CA 92121Responsible for clinical monitoring activities and overall project administration to oversee the progress of multi-center, investigator-initiated, or industry-sponsored clinical studies throughout the western United States.Responsible for all site management and trial administration aspects as prescribed in the monitoring plans, and protocol and as directed by the Program Manager.Verify study participants by confirming informed consent and protocol procedures have been performed in accordance with applicable regulations.Responsible for working with sites providing ongoing training, remote monitoring, and interim field monitoring and close-out visits.Evaluate onsite and remote monitoring activities such as the following: clinical data documentation, regulatory document review, monitor safety, and conduct of a study to ensure investigator and site compliance with the study protocol, overall clinical objectives, FDA regulations, ICH/GCP guidelines, institutional/ CRA SOPs, and HIPAA guidelines.Work cooperatively with the study team and operation management to proactively accomplish the project objective.Proactively participate in CRA program development. This includes contributing to the overall quality improvement of clinical monitoring service and actively collaborating with program leadership to expand and grow the CRAs professional portfolio.Responsible for internal quality control process for assigned monitoring activities and contributed to improving and adapting quality control procedure. Align service goals with internal and external client expectations.Responsible for timely reporting of all monitoring visit findings, completing comprehensive monitoring reports and associated deliverables to the Sponsor and the clinical sites.Responsible for managing all monitoring visit travel arrangements and travel expense reporting activities in accordance with Quintiles travel and expense purchasing policy.Barrow Neurological Institute Clinical Research Organization 240 West Thomas Road Phoenix, AZ 85013Responsible for clinical monitoring activities and overall project administration to oversee the progress of multi-center, investigator-initiated, or industry-sponsored clinical studies throughout the United States.Responsible for all site management and trial administration aspects as prescribed in the monitoring plans and as directed by the Program Manager.Responsible for working with sites providing ongoing training, remote monitoring, and interim field monitoring and close-out visits.Evaluate clinical data documentation, regulatory document review, monitor safety, and conduct a study to ensure investigator and site compliance with the study protocol, overall clinical objectives, FDA regulations, ICH/GCP guidelines, institutional/ CRO SOPs, and HIPPA guidelines.Work cooperatively with the study team and operation management to proactively accomplish project objectives.Proactively participate in BNI CRO program development. This includes contributing to the overall quality improvement of clinical monitoring service and actively collaborating with program leadership to expand and grow the CROs professional portfolio.Responsible for internal quality control process for assigned monitoring activities and contributed to improving and adapting quality control procedure. Align service goals with internal and external client expectations.Responsible for timely reporting of all monitoring visit findings, completing comprehensive monitoring reports and associated deliverables to the Sponsor and the clinical sites.Responsible for managing all monitoring visit travel arrangements and travel expense reporting activities in accordance with Dignity Healths travel and expense purchasing policy.Clinical Research Consortium/ Allied Multispecialty Research Tempe, AZInitiating/managing studies, and delegating responsibilities on the Delegation log of Authority per protocol.Maintain up-to-date regulatory documents including site start-up and Independent Review documents, as well as obtaining and maintaining up-to-date Curriculum Vitae and licensing for all site investigators and study staffTraining of investigators and staff not present at Investigator Meetings or Site Initiation Visit in proper study protocol and execution to ensure accuracy of data and maintenance of study blind.Initial reporting and update of Serious Adverse Events to IRB and study sponsors in a timely manner to ensure subject safety.Processing of lab specimens for accurate Immunogenicity and Pharmacokinetic results in multiple studiesResponsible for all clinics to work up patients: phlebotomy, collecting medical history, and concomitant medicationsFollow GCP and Human Subject procedures for trials in enrolling and ongoing studies.RETINAL CONSULTANTS OF ARIZONA LTD/RETINAL RESEARCH INSTITUTE LLC Phoenix, AZMaintain up-to-date regulatory documents including site start-up and Independent Review documents, as well as obtaining and maintaining up-to-date Curriculum Vitae and licensing for all site investigators and study staffTraining of investigators and staff not present at Investigator Meetings or Site Initiation Visit in proper study protocol and execution to ensure accuracy of data and maintenance of study blind.Initial reporting and update of Serious Adverse Events to IRB and study sponsors in a timely manner to ensure subject safety.Processing of lab specimens for accurate Immunogenicity and Pharmacokinetic results in multiple studiesResponsible for all occasional assistance in the clinic to work up patients: collecting medical history, vision examination, intraocular pressure, Amsler grid testing, external ocular motility testing, confrontational fields, and dilation.Assist as needed with intra-ocular injections and minor surgical procedures.Follow GCP and Human Subject procedures for trials in enrolling and ongoing studiesEducationArizona State University (2009) Bachelor of Science: American Indian Studies Magna Cum Laude, American Indian Studies Achievement Honors, Directors List 2008, Deans List 2007San Diego Community College (2001) Associate of Arts: General StudiesMesa Community College (2017) Anatomy and Physiology/Medical TerminologyArizona State University (2023)/ Currently attending graduate school for Clinical Research Master's Degree in Clinical Research Management with an emphasis in scientific regulatory.HonorsFeller Award (2015) Patient Service ExcellenceU.S. Navy/Marine Veterans (2002) Customer Service AwardSpectrum Award, Southern California (2002) Customer SatisfactionUS Navy (1998) Honorable DischargeCommunity ServicePhoenix Rescue Easter Mission Event 2022Veterans Missing In American Project 2021Phoenix Rescue Easter Mission Event 2021Phoenix Rescue Mission Support Center 2019Phoenix Rescue Mission Support Center2013White Mountain Apache Elders Health Program 2011Hopi Special Diabetes Program 2010Pueblo of Zuni Elders Day 2010San Carlos Apache Elders Day 2010Intertribal of Arizona Dental Sealant Program 2009Tijuana Children Christmas Toys Benefit 1999Acapulco Health Support U.S. NavyWhiteriver Indian Hospital 1994 |
