Registered nurse for 29 years with experience in diverse health settings. Clinical Research Associate with 20 years monitoring experience in Single Patient IND and Phase 2 to Phase IV clinical studies.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Registered Nurse
University Medical Center Of El Paso
03.2021 - 05.2022
Performed Covid Vaccine administration following CDC Guidelines and UMC SOPs .
Managed Daily Covid Vaccine Clinic activities from preparation, administration, and system entries of 25 to 300 vaccines per day.
Audited charts and reviewed clinical documents to verify accuracy.
Updated Covid Vaccine and Influenza Vaccine administrations in EMR and Imm-Trac systems to maintain records current.
Trained new nurses and nursing assistants in proper vaccine techniques, care standards, operational procedures, and safety protocols for Covid Vaccine Clinic.
Clinical Research Associate
IQVIA
01.2019 - 02.2021
Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion for upcoming database locks, interim analysis deadlines, or study closure.
Ensured patient safety, appropriate documentation of consent process, protocol compliance and data quality in EDC systems (CTMS, Medidata, Inform).
Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
Monitored clinical studies in Dermatology, Rheumatology, and Neurology, including double blinded studies.
Performed PSSV, SIV, IMV, and COVs as onsite or remote visits.
Conducted approximately 10-15 PSSVs, 5-10 SIVs, 50-100 IMVs, and 5-10 COVS.
Clinical Research Associate
PRA Health Sciences
05.2000 - 01.2018
Managed sites to conduct clinical trial in accordance with protocol, ICH/GCP, and regulatory requirements.
Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Conducted pre-selection, initiation, Interim and close out monitoring visits per study management plan to verify study procedures, regulatory documents and data integrity.
Monitored clinical studies in Pedi-Oncology, Oncology, Hematology, Neurology, and Gastroenterology from Single Patient IND, Phase 2 to Phase 4 clinical studies, including double blind, open label, dose escalation and cohort studies.
Performed onsite or remote PSSV, SIV, IMV, and COV with breakdown of approximately 100-150 PSSVs, 75-100 SIVs, 300-500 IMVs, and 75-100 COVs.
Registered Nurse-Pediatric Call Center
St Peters University Hospital
05.1997 - 05.2000
Triaged Non-Emergency health issues for pediatric patients during non office hours, nights and weekends or holidays .
Utilized nursing process and diagnosis to assess, plan, implement and evaluate patient care per St Peter SOPs. and Call Center Management Plan.
Educated patients and families on health topics, medications and treatments to increase understanding and improve health outcomes.
Registered Nurse
El Paso City County Health District
09.1992 - 01.1997
Educated patients, families and caregivers on diagnosis and prognosis, treatment options, disease process, and management and lifestyle options.
Administered medications and treatment to patients and monitored responses while working with healthcare teams to adjust care plans.
Provided direct patient care in Well Baby, PreNatal, Diabetes, Immunization and Travel Immunization Clinics and auditor for QA division.
Registered Nurse- Pediatric- Pedi Oncology
Providence Memorial Hospital
03.1992 - 08.1992
Administered chemotherapy, blood products,
Implemented nursing diagnosis care plan for quality patient care.
Educated family members and caregivers on patient care instructions.
Education
Bachelor of Science - Nursing
The University of Texas At El Paso
El Paso, TX
05.1991
Skills
Patient Eligibility Verification
Protocol Adherence
PI and Site Staff Training
Informed Consent Review and Compliance
ICH GCP Compliance
Adverse Event and SAE Management
Source Data Verification and Quality Control
Monitoring Visits (Pre, SIV, IMV, and COV)
Managing Deadlines and Database Locks
Team Coordination
Site Management
Experience with various clinical research systems (Medidata, Inform, CTMS)
Languages
Spanish: Proficient in verbal and reading; intermediate level in writing.
Registered Nurse, Intensive Care Unit at University Medical Center of El PasoRegistered Nurse, Intensive Care Unit at University Medical Center of El Paso