Experience

Children's Oncology Group

• United States
• Research Services
• 1 - 100 Employee

• Research Coordinator 1

  • Nov 2022 - Present



Optum

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Coordinator

  • May 2019 - Nov 2022

  Phases 2+ studies Study population: Pediatrics (I.e healthy infants, adolescents) and adults. Indication: Pediatrics- Vaccine study (varying from Meningococcal, pneumococcal and RSV). Adults- Investigational product that observes outcomes in cardiovascular health, type 2 diabetes, etc. - Collaborates with the Principle Investigator and Sub-investigator to review and verify required source documents in subject’s medical record to confirm study eligibility. - Conducts interviews to assess the subject’s ability and willingness to follow and complete study procedures and visits. - Obtains informed consent from research subjects prior to any study-related procedures and documents appropriately. - Maintains patient screening enrollment logs. - Timely data entry, query solution, AE and SAE reporting. - Randomize subjects and dispense Investigational Product. When appropriate, prepare and administer Investigational Product. - Receive Investigational Product and maintain inventory of Investigational Product at a site level and subject level. - Performs phlebotomy to collect, process and ship samples as required. - Applies knowledge of study design to assist in evaluation of protocol feasibility at the site. - Create source documents to capture the correct data per protocol and eCRF guidelines. - Perform regulatory maintenance pertaining to study start up, Continuing Reviews, close-out requirements and relevant communication print-outs for multiple research studies and sites. - Ensure Investigator Site File is up-to-date with all forms- IRB interaction, updated FDA 1572, Financial Disclosure Form, Delegation of Authority log, site training log, etc. - Review study contract to assure Sponsor is being billed appropriately. - Attends and participates in investigator meetings as directed. - Prepares source documents and regulatory binders for routine monitoring visits and sponsor audits. Show less



University of Colorado Denver

• United States
• Higher Education
• 700 & Above Employee

• Clinical Research Coordinator

  • May 2018 - May 2019

  Phase 2+ studies Study population: Hepatology, focusing on PSC and PBC. - Collaborated with principal investigators and co-investigators to enroll clinical trial patients. - Conducted study visits. - Overall compliance with the policy and procedures for conducting good clinical trials. - Screened, consented and enrolled study participants. - Collected, processed and stored samples for research. - Medication compliance tracking and coordinated protocol procedures. - Collected and reported all patient reported adverse drug reactions and other serious adverse events. - Patient education and follow-up per protocol guidelines. - Routine meetings with monitors to reconcile data management issues. - Participated in investigator’s meetings. - Prepared and submitted compliance documentation for the institutional review board. - Submitted to the Human Research Subjects Portal for UCH-RSS review and approval. - Maintenance of databases. - Abstracted data from patient charts and electronic medical records. Show less



University of Miami

• United States
• Higher Education
• 700 & Above Employee

• Research Associate

  • Jun 2017 - Feb 2018

  Phase 1+ studies Indication: Oncology- Assisted the Clinical Research Coordinators ensuring that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner.- Assisted in the completion of protocol specific documents. Obtain relevant medical information from patient clinic charts/medical records. Maintain logs/progress reports to track both currently enrolled as well as follow-up participants. Provide protocol specific study documentation required in the management of study patient as per the protocol, federal regulations, and sponsor requirements and as required per UM policy.- Entered data onto case report forms and/or into computer database. Completes corrections/queries required at audits/monitor visits in a timely manner. Ensures data integrity and consistency in computer database and written records by reviewing entered data for accuracy.- Assisted the Clinical Study Coordinator to maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.- Ensured that randomization and registration of patients are performed in compliance with CRS and UM policies, the protocol, ICH-GCP, and federal regulations. Show less

• Graduate Research Assistant

  • Sep 2015 - Jun 2017

  - Produced graphs, figures, and tables for dissemination of project findings using Excel, SPSS, and SAS.- Performed literature reviews and chart reviews.- Managed IRB protocols, consent forms, and created focus group scripts.- Build and manage REDCap surveys.- Reviewed and extract data from patient's Electronic Medical Record.