Data Entry Spanish Interpreter

Rosse Rodriguez

Clinical Research Coordinator

**** *. **** *****, ***. D-203, Arvada CO 80002

720-***-**** *****.*********@*****.*** linkedin.com/in/rosse-rodriguez-73665441 Professional Summary

A Clinical Research Data Coordinator and a foreign-trained medical doctor, bilingual in Spanish & English, who is involved in managing and coordinating clinical research and clinical trials. Monitors activities to assure adherence to Good Clinical Practices (GCPs), Scope of practices (SOPs), and study protocols. Reviews regulatory documents as required and prepares site visit reports. Records collected subject data promptly and efficiently into study data systems while maintaining HIPAA compliance. Ensures the safety and welfare of all study subjects. Core Competences

Leadership Clinical Research Infectious Disease

Infection Control Pediatrics Autism

Public Health Gynecology Educator

Health Coach Microsoft Office GCP trained

Customer Services Clinical Trials Public Speaking

Clinical Data Management Citi Certified EPIC

REDCap Open Clinica Medidata

Professional Research & Work History

Western Nephrology, Arvada CO

Clinical Research Coordinator Nov. 11, 2022- Present

• Coordinate and perform all study related duties • Screen, enroll, consent patients. Prepare, submit, and maintain regulatory compliance – WIRB, COMIRB: initial submissions, and maintain regulatory compliance, including initial submissions, amendments, continuing reviews, and adverse events reporting • Follow up study participants throughout the study life cycle • Take Vital signs, ECG, Spirometry, data collection. Collect, process, and ship clinical specimens such as blood and tissue cultures • Ensure research team protocol compliance and responsible conduct of clinical trials using established GCP guidelines • Data management in multiple database formats (INFORM, Meta base, Open Clinica, Medidata, etc) • Conduct charts reviews and record clinical study findings • Assess laboratory reports and clinical data in conjunction with the PI • Ensure patient compliance and follow-up with study related visits • Complete study related source documents and ensured that case report forms are complete after each study visit • Maintain inventory of all supplies needed for clinical trials including study drugs and devices, lab kits, and medical supplies Coordinate and manage correspondence with regulatory bodies, finalize IRB documentation and prepare study documentation for approval. Train in GCP, ICH, FDA, and local regulations for drug and device trials. Allianz Research Institute, Denver CO

Clinical Research Coordinator July 25, 2022 – October 25, 2022

• Coordinate and perform all study related duties • Screen, enroll, consent patients. Prepare, submit, and maintain regulatory compliance – WIRB, COMIRB: initial submissions, and maintain regulatory compliance, including initial submissions, amendments, continuing reviews, and adverse events reporting • Follow up study participants throughout the study life cycle • Take Vital signs, ECG, Spirometry, data collection. Collect, process, and ship clinical specimens such as blood and tissue cultures • Ensure research team protocol compliance and responsible conduct of clinical trials using established GCP guidelines • Data management in multiple database formats (INFORM, REDCAP, Meta base, Open Clinica, Medidata, etc) • Conduct charts reviews and record clinical study findings • Assess laboratory reports and clinical data in conjunction with the PI • Ensure patient compliance and follow-up with study related visits • Complete study related source documents and ensured that case report forms are complete after each study visit • Maintain inventory of all supplies needed for clinical trials including study drugs and devices, lab kits, and medical supplies Coordinate and manage correspondence with regulatory bodies, finalize IRB documentation and prepare study documentation for approval. Train in GCP, ICH, FDA, and local regulations for drug and device trials. I-SPY COVID TRIAL Quantum Leap Healthcare April 2021- July 2022

An Adaptive Platform Trial to reduce mortality and ventilators requirements for Critically Ill Patients. Collects and accurately records study data in source documents and case report forms. Assures IRB approval is obtained before beginning any procedures. Assist 20 sites assigned in the USA and contributes to the patient and site operational plans.

Denver Health Hospital & Authority, Denver CO October 2015 – March 2020 Clinical Research Data Coordinator

Coordinates with site management and Principal Investigator to help ensure that collected subject data is in accordance with study protocol, Good clinical practice, ICH/GCP, Federal regulations, and sponsoring agency policies and procedures. Reports instances of noncompliance to site management. Attends site initiation visits for data entry training as required. Ensures no delays or issues with data entry during study start-up, study administration, and study closeout. Reports instances of chart incompleteness and inconsistencies. Denver Health Hospital & Authority Study: Vaccine Hesitancy in Pediatrics April 2019 - March 2020

Prepared, submitted, and maintained regulatory compliance – WIRB, COMIRB: initial submissions and maintained regulatory compliance, including initial requests, amendments, continuing reviews, and adverse events reporting. Followed up with pediatric patients with survey questions. Data entry RedCap. Denver Health Hospital & Authority Study: Cancer Health Assessments Reaching Many (CHARM) June 2018 - April 2019

Responsible for creating MOP procedures. Ensured patient compliance and follow-up with study-related visits. Completed source documents and ensured that case report forms were completed after each study visit. Denver Health Hospital & Authority Study: Implementation of Health Literacy Universal Precautions. October 2017 - March 2018

Monitored patient satisfaction, medication adherence, and disease outcomes. Performed data entry, Developed Excel spreadsheet analysis and surveys, and followed up with patients. Denver Health Hospital & Authority Study: Access to Naloxone: Denver Health and Kaiser Permanente December 2017 - April 2018

Ensured research team protocol compliance and responsible conduct of clinical trials using established GCP guidelines. Performed data management in EPIC and conducted charts reviews, and recorded clinical study findings. Assessed laboratory reports and clinical data in conjunction with the PI. Ensured patient compliance and followed up with study-related visits. Complete study-related source documents and ensure that case report forms are complete after each study visit. Denver Health Hospital & Authority Study: Improving Health Education: The primary Care Health Educator September 2017 - January 2018

Data management Red Cap. Conducted Charts reviews and recorded clinical study findings. Ensured compliance and followed-up related to patients' visits. Denver Health Hospital & Authority Study: Team-Based Care, Quality Improvement Project June 2017 - November 2017

Assisted Primary Investigator I with quality improvements project in Lowry clinic Denver Health Hospital & Authority Study: Hepatitis C and Increased Risk for Nonadherence to Treatment August 2017 - September 2018

Prepared, maintained regulatory compliance, Screened, recruited, and enrolled study participants. Denver Health Hospital & Authority Study: Blood Stream Infections due to Staphylococci: October 2015 - September 2018

Sponsor Duke Clinical Research Institute, coordinated and performed all study-related duties. Denver Health Hospital & Authority Study: A Phase 3 Multicenter, Randomized, Open-Label, Clinical Trial of Telavancin vs Staphylococcus Aureus Bacteremia Including Infective Endocarditis July 2016 - September 2018

Coordinated and performed all study-related duties. Prepare, submit, and maintain regulatory compliance. Denver Health Hospital & Authority Study: Biomarker Kinetics in Acute Bacterial Skin and Skin Structure February 2015 - January 2017

WIRB, COMIRB: Initial submissions and maintain regulatory compliance. Denver Health Hospital & Authority Study: Autism Patient Navigator University of Colorado, Boulder CO December 2014 - February 2015

Provided early screening for autism, helping patients navigate health systems, overcome barriers to care, and access quality care. Provide various services such as patient counseling, treatment adherence, assessments, and screenings.

Patient Navigator

Health Denver Hospital & Authority, Denver CO October 2013 - November 2014

Healthy Lifestyle Clinic helped patients from 2 to 18 years old with nutrition, exercise, and healthy lifestyle changes to improve health and reduce obesity and Diabetes. At the Eastside clinic involved in Research Interventional study "Healthy Family Program." Conducted home visits with families to help children between the ages of two through six eat healthy, exercise, and overweight prevention. Sterilization and Disinfection Specialist

3M Corporation, El Salvador 1998 - 2008

Regional physician services in infection prevention for Panama, Costa Rica, and El Salvador. Managed the Medical Division and trained in the area of continuing education for health care professionals in sterilization and disinfection, skin and wound care, and operating room practices. Education

MD Doctor of Medicine, Universidad Salvadoreña Alberto Masferrer San Salvador, El Salvador 1985-1992

Certifications & Trainings

CITI Certified October 2021 - October 2024

GCP Certified October 2021 - October 2024

Certified Spanish Interpreter, Denver Health Hospital March 2014 REDCap Training January 2015

Certified Phlebotomy Technician Certificate Number - N22105700 Issue Date – 11-05-2022, expiration 11-30-2024

Publications

Manual de Desinfección y Esterlizacion en Hospitales de la Red Nacional de Hospitales en El Salvador, Ministerio de Salud Publica.

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