Summary
Overview
Work History
Education
Skills
Professional Collaborations
Independent Research
Timeline
Generic

Iesha Miller

Sacramento,CA

Summary

Experienced clinical trials coordinator and aspiring data manager looking to expand skillset by moving from patient recruitment to operations management.

Overview

13
13
years of professional experience

Work History

Senior Clinical Data Coordinator

VANGUARD CLINICAL, INC.
03.2022 - Current
  • Responsible for data entry activities on a multicenter oncology trial at a top research institution, quality control review, identification and documentation of data problems during CRF tracking
  • Performs proficient reviews of study source prior to clinical data entry
  • Reviews enrolled subjects’ clinical and external data, entered in EDC, based on programmed edit checks specifications
  • Analyzes and validates data to maintain regulatory compliance and improve study effectiveness
  • Coordinates with cross-functional teams to ensure timely data analysis and documentation submissions to applicable regulatory agencies
  • Assists in the closure of site data queries in the EDC and follow-up on safety issues and safety reports in a timely manner
  • Proactively identifies, documents, and assists in the resolution of issues relating to subject recruitment, study data quality, and study conduct at assigned study sites
  • Maintains awareness of study events and associated data and documentation requirements through collaboration with functional/sub-functional area study team-members
  • Participates in required study meetings
  • Audits/reviews internal and external logs (ex
  • Device accountability, training, delegation of authority (DOA)
  • Conducts internal and/or site training as needed and serves as a point of contact for study-related questions and other issues from study sites and site monitors
  • Ensures all protocol procedures are ordered and completed as specified in the protocol
  • Optimizes the safety of research subjects by ensuring any adverse events (AE) are appropriately reported to the sponsor, study team and institution according to protocol and regulatory requirements
  • Abstracts data from the medical record and completes paper and electronic CRFs including responding to any requests for data clarification
  • Ensures data accuracy with source documentation
  • Ensures documentation processes are followed according to GCP
  • Maintains all necessary patient source documents for assigned studies
  • Obtains data, including images, specimens and medical records, from outside facilities, as needed
  • Responds to all requests for data clarifications of assigned studies
  • Meets contractual or institutional requirements for timeliness of data entry and query resolution
  • Fulfills sponsor requirements related to reportable information, including AE, unanticipated problems, other information required by the sponsor protocol
  • Schedules and participates in interim monitoring visits (IMV) for source data verification (SDV)
  • Reviews monitoring reports for assigned studies, determines any discrepancies and resolves outstanding data issues identified by the monitor
  • Participates in audits and monitor visits for assigned studies, as requested
  • Identifies and communicates important protocol and data issues or problems to the PI and supervisor in a timely manner.

Pediatric Clinical Research Coordinator

UC Davis Health System
11.2018 - Current
  • Assist physicians with project management from start up to end, including protocol drafting, IRB submission, recruitment and patient management and study close out
  • Responsible for all aspects of study management including patient and provider study compliance, data entry, chart review and trouble shooting
  • Strong attention to detail and ability to work independently
  • Strong problem solving skills and ability to manage conflicting demands and priorities
  • Proficiency in Microsoft Office Programs and various other data management programs
  • Current project management includes NICU, PICU, breastfeeding, telemedicine and coordination of industry trials including feasibly and budgeting
  • Strong team building skills and leader in the work group tasked with assisting with the orientation of new hires and students to the department.

Field Operations Team member

Applied Therapeutics
06.2021 - 06.2022
  • Assist CTR staff with the recruitment and enrollment in the ARISE-HF study
  • Responsible for chart review, patient screening, assistance with scheduling and any other study specific requirements
  • Responsible for the initiation and management of local echocardiogram clinic, including echo tech retention, schedule management and participant scheduling
  • Also implemented the roll out and management of Study Cast PACS system at site.

Clinical Trials Coordinator

Sutter Health
02.2018 - 11.2018
  • Assisted with the enrollment of patients into the GRAIL Strive Study
  • Consented patients, assisted with questionnaires and answer any study or cancer related question for participants.

Oncology Clinical Trials Coordinator

KAISER PERMANENTE
02.2017 - 02.2018
  • Responsible for assisting with clinical investigators and coordinators, including but not limited to: study start-up, assistance with financial aspects of clinical trials, FDA documents, IRB documents, HIPAA compliance, source documents and CRFs, research subjects scheduling and registration, sponsor site visits, recruitment and retention strategies, laboratory specimen processing and shipping, monitoring visits and audits, close-out procedures, etc.

Pathology Technical Assistant AA

KAISER PERMANENTE
09.2013 - 02.2017
  • Responsible for assisting pathologists and CPA with the grossing of complex specimens
  • Responsible for grossing small biopsies including gastrointestinal, gynecological, and dermatopathological specimens
  • Also responsible for specimen receipt from various departments and working with originating departments to resolve issues impacting patient care, and training new hires on workflow processes
  • Provides administrative assistance to department manager and all departmental sections
  • Responsible for maintaining service schedules, case assignments, mail distribution and other general office tasks
  • Tasked with ensuring work section is compliant with various policies prior to quality surveys and audits
  • Team lead experience as a Dragon Dictation System Super User.

Front Office Lead

Peach Tree Health
06.2016 - 09.2016
  • Responsible for facilitating the efficiency of schedule maintenance and registration for the family practice practitioners of a FQHC
  • Acts as the first point of contact for patients and other guests in the clinic
  • Responsible for providing exceptional customer service, insurance verification and assisting patients with any troubleshooting as needed
  • Assisted with the transition from paper to electronic medical records and transition of organization to the Sacramento area
  • Responsible for completing medical record requests for patients and outside clinics
  • Also function as the lead for a group of employees working in the front office of the family practice, vision and immediate care departments in the clinic.

HCLA III

UC Davis Health System
04.2011 - 05.2014
  • Responsible for interpreting the Anatomical Pathology Service schedule on a daily basis to assist management with workflow and case assignment
  • Assisting faculty and grossing room staff with receiving and accessioning surgical specimens
  • Responsible for assisting with preparation of H&E stained slides used in frozen section diagnoses
  • Also responsible for the tracking and disposal of medical waste, transporting specimens, slide tracking and distribution
  • Responsible for interpreting the Anatomical Pathology Service schedule on a daily basis to assist management with workflow and case assignment
  • Additionally, responsible for training new hires on workflow processes in department.

Education

No Degree - Data Management For Clinical Research

Vanderbilt University
11.2023

Master of Healthcare administration -

University of Phoenix
12.2014

Bachelor of science, biological sciences -

CSU sacramento
05.2010

Skills

  • Data Organization
  • Advanced Data Mining
  • Database Finalization
  • Quality Control
  • Database Design
  • Strong attention to detail
  • Ability to manage competing priorities

Professional Collaborations

  • Hoyt-Austin A, Miller I, Kuhn-Riordon K, Rosenthal J, Hoffman K, Kair LR, A Qualitative Analysis of the Impact of Videoconferencing with the Premature Infant on Breast Milk Expression, SEARCH 2020 National Telehealth Research Symposium, 11/11/2020, Virtual
  • Carranza J, Gipson A, Miller I, Hoyt-Austin A, Chen MJ, Price CA, Muriki M, Moody E, Barajas-McGahan M, Schwarz EB, Kair LR, Golden Journey Empowerment and UC Davis Collaborative, UC Davis Public Scholarship and Engagement, 08/27/2020, Available at: https://publicengagement.ucdavis.edu/blog/celebrating-black-breastfeeding-week

Independent Research

  • Introduction to Scientific Research, California State University, Sacramento, 2006, Conducted research on the effects of yellow star thistle on breast cancer under the supervision of a professor and presented findings at a conference.
  • Independent Literature Research, California State University, Sacramento, 2008, Conducted extensive research on published literature suggesting a link between the occurrence of breast cancer in women of color and vitamin D deficiencies.
  • Capstone Project, University of Phoenix, Sacramento, 2014, Conducted extensive research on published literature suggesting a possible link between socioeconomic conditions and adverse birth outcomes in women of color.

Timeline

Senior Clinical Data Coordinator

VANGUARD CLINICAL, INC.
03.2022 - Current

Field Operations Team member

Applied Therapeutics
06.2021 - 06.2022

Pediatric Clinical Research Coordinator

UC Davis Health System
11.2018 - Current

Clinical Trials Coordinator

Sutter Health
02.2018 - 11.2018

Oncology Clinical Trials Coordinator

KAISER PERMANENTE
02.2017 - 02.2018

Front Office Lead

Peach Tree Health
06.2016 - 09.2016

Pathology Technical Assistant AA

KAISER PERMANENTE
09.2013 - 02.2017

HCLA III

UC Davis Health System
04.2011 - 05.2014

No Degree - Data Management For Clinical Research

Vanderbilt University

Master of Healthcare administration -

University of Phoenix

Bachelor of science, biological sciences -

CSU sacramento

Similar Profiles

CREATE PROFILE
Iesha Miller