Primary In House CRA in Contact for Investigation Sites and Assisting with Document Reconciliation, Data review and ensuring protocol adherence with patient safety as a top priority, Maintaining Investigator and staff training, ICH-GCP,and regulatory compliance.
Follow up on Data Discrepancies on patient data capture to ensure patient safety.
Oncology Clinical Trial and Vaccine Clinical Trials, Site Trial Communication and Staff Education,Document and Audit Collection ,eTMF, Query Generation ,Query Resolution , Data Management , Data Review, Provide Assistant to lead researchers , Monitor Clinical Trial, Administrative support, Sites Data Collection, Data Management , remain in compliance with field and government regulations,Regulations in Human Subjects Research.
Clinical Research Coordinator
UCSD Moore's Cancer Center
03.2022 - 10.2022
Multiple Oncology/Hematology Experimental Clinical Trial, subject recruitment into clinical trials , laboratory procedures and interpreting them to determine patient eligibility and potential toxicities.
Working with FDA policies regulating clinical trials Informed Consent,Data Collection and Submission.
Treatment plans , study startup activities, Coordination with patient and physician Oncologist, ,Lab Appointment and Imaging Schedule
EPIC, MediData
Electronic remote meeting applications Zoom and Microsoft Teams.
Clinical Research Coordinator,PFIZER RSV
InsightGlobal/WCG Threewire
08.2021 - 03.2022
Data Submission, CRF , DCF Submission ,Data Reconciliation, Clinical Support,Clinical Evaluation, Queries Resolution ,Chart Review, eDiary Training and Reminders, Administrative Support ,Clincard payments, ,Assessment Respiratory Illness Visit ,Follow up Respiratory Illness Visit , Nasal Swab Collection ,Follow up visits and Follow up Calls, Vitals Signs ,track participant enrollment in the Pfizer RSV study.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Women's Health Case Manager Oncology
Family Health Centers Of San Diego
01.2021 - 06.2021
Health education, Project Management, Clinical Evaluation , clinical support , breast cancer supportive services such as eligibility determination for low income patients, enrollment assistance, Consent Form, Patient education and support.
International Nurse Graduate,Back Office Assistant
My Chula Vista Doctors
01.2018 - 01.2020
Clinical Evaluation, Back office duties, Clinical Support ,Vaccination Pediatrics and Seniors patients, AHA.
Patient Education, Patient intake vital signs, organized and complete electronic health records.
EKG, Stitch Removal, assisting physicians on colposcopy and other in-house procedures.
Consent form for procedures , Vaccine Temperature log for VFC program, VFC program in charge.
Registered Nurse ,Pediatric Nurse
General Hospital of Tijuana
01.2016 - 01.2018
Pediatric Oncology/Hematology/; Hospitalization, administering chemotherapy, vital signs, assessing patients pre-during-post chemo, collaborating with other members of health, Clinical support.
Education
Bachelor of Science - Nursing
University Autonomous Of Baja California
Ensenada Mexico
07.2016
Skills
Nursing
Clinical trials
Oncology
Remote Clinical Monitoring
Clinical Documentation Chart Review
EHR
Health Care knowledge
Task Management
Task List Time Management
Problem solving
Research Skills
Clinical Research
Team Work
Data Entry
Project Management
Strong Organization Skills
Microsoft Office (outlook calendar , teams meeting, agenda, check list)
Organization and Time Management
Time Management
Operation
Software Proficiency
Related Experience
Volunteer Registered Nurse, Flying Samaritans San Diego State University, 2018, 2020, Tijuana, Baja California, Triage and screening , high risk patients with chronic medical conditions in low- income communities in Tijuana Baja California.
Internship/Social Service, General Hospital of Tijuana, 2017, 2018, Tijuana
Clinical Rotations, Multiple Hospitals, 2012, 2016, Internal Medicine, Emergency Department, OR, ICU, Public Health, Geriatrics,pediatrics , Public Health , epidemiology, Family Medicine.
Certification And Licensure
Bachelor science of Nursing Diploma
Mexico Registered Nurse, License Number 11853999. State of Baja California
Good Clinical Practice Certificate
IATA Certificate
CITI GCP Certificate
COVID 19 and Human Research Protection Programs
Child Abuse Reporter Training For New York State Deparment
Bloodborne Infections I : Bloodborne Viruses
COVID 19 Prevention In California
First Aid CPR AED,American Heart Association
Basic Life Support, American Heart Association
Pediatric Oncology Certification (Mexico)
Wound Care and Diabetes Management (Mexico)
Languages
SPANISH (read , speak and write)
ENGLISH (read, speak and write)
Associations
American Nurse Association/ ANA
Software Emr Edc
ELECTRONIC DATA CAPTURE , Oracle InForm
ETMF Veeva Vault
Clinical Conductor
CRIO Research IO
EPIC Systems corporation
EClinicalWorks
Drug Dev
CMIS 2.0
EHR 2.0
EDC Medidata Rave
Timeline
In House Clinical Research Associate
ICON Clinical Research
10.2022 - 10.2023
Clinical Research Coordinator
UCSD Moore's Cancer Center
03.2022 - 10.2022
Clinical Research Coordinator,PFIZER RSV
InsightGlobal/WCG Threewire
08.2021 - 03.2022
Women's Health Case Manager Oncology
Family Health Centers Of San Diego
01.2021 - 06.2021
International Nurse Graduate,Back Office Assistant
Operations Recruitment Manager - Patient & Site Engagement at ICON Clinical Research (in partnership with Johnson & Johnson)Operations Recruitment Manager - Patient & Site Engagement at ICON Clinical Research (in partnership with Johnson & Johnson)