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Clinical Trial Research

Location:
Des Moines, IA
Posted:
February 26, 2024

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Resume:

I am an energetic, creative health science professional who is looking to grow in an industry that impacts the safe delivery of services and resources to clinical research patients. A large portion of my health professional career has been dedicated to Study Trial Development in various roles including Clinical Trial Monitoring, Clinical Trial Coordination, Research Data Management and Regulatory/IRB Compliance. In my more recent roles, I worked as a Community Health Worker, Clinical Trial Data Management Assistant, Real World Evidence Clinical Trial Site Manager, and in the Safety Operations Coordinator for the Moderna COVID-19 Vaccination Project.

EDUCATION:

Bachelor of Biology, Magna cum Laude, Martin University, Indianapolis, IN

Health and Wellness Certification, Dr. Sears Wellness Institute

Master Project Management Certification, DeVry Keller Graduate School of Management, (Anticipated date of completion is July 2024)

SKILLS SUMMARY:

Pharmaceutical Trial Development, Study Drug Safety Coordination, Argus Safety Data System Clinical Trial Data Management, Study Trial Coordination, Research Compliance Coordination (IRB), Clinical Trial Materials Management, and Health and Wellness, Motivational Interviewing, Sterile Processing Micro-systems (SPM),,RedCap, Micro-Soft Office, Oracle Share Point (IMPACT/CERNER/INFORMM), RepTrak -Vendor Management Software Systems, Lotus Notes, Outlook, Business Development, Business Consultant, Lean/Six-Sigma/Process Improvement, Supply Chain Analysis, Career Development and Mentorship Coordination. Motivational Interviewing, Project Management.

WORK HISTORY:

MercyOne Des Moines Iowa Medical Center, OBED and Antepartum Community Health Worker, December 2022-Present: Support Grow Baby Grow grant project in the role of Community Health Worker. Project’s main objective was to improve health outcomes and reduce stillbirths for women of color in the Des Moines community.

Utilize data collected for ongoing process improvement methods.

Increase pregnant women’s access to culturally, financially, socially, and emotionally relevant resources and services.

Cynet Health: Clinical Trial Monitor 2 at IQVIA: October 2021 – March 2022. Coordinated clinical studies at the study site management level overseeing study trial processes and site initiation, site staff study training and regulatory and site monitoring execution during various stages of study site management, including remote study site start up, remote site initiation visits and remote site level study monitoring.

Accomplishments:

SpectraForce Technologies: Safety Operations Coordinator 2, Data Science and Regulatory department, Lifecycle safety at IQVIA, April 2021-July 2021. Assisted in processing of Lifecycle Safety Data by collecting and tracking incoming Adverse Events (AE) in Argus Safety Database Systems, endpoint information, determining initial/update status of incoming events, tracking timelines for completion of event processing for COVID-19 mRNA 1273 Emergency Use Authorization Vaccinations.

Accomplishments:

Assisted with project workflow including database entry, quality control activities, and generation of Lifecycle Safety data reports, preparation of Lifecycle Safety submission

Clinical Trial Data Management Coordinator for Institute of Clinical and Translational Science, University of Iowa Hospitals and Clinics, Dept. of Internal Medicine, April 2016 to October 2019. Assisted with assessment screening, recruiting, and consenting of 200 study families for Living Well Together Family Obesity Prevention Clinical Research Trial. Assisted with assessment screening, recruiting, and consenting of 200 study families for Living Well Together Clinical Research Trial. Scheduled and completed study visits, performing biometric assessments, patient questionnaire surveys, and health and wellness coaching in compliance to study procedures. Prepared and arranged for delivery of highly sensitive study trial materials from Institute of Clinical and Translational Sciences quality assurance laboratories and designated warehouses to clinical study sites in a timely manner.

Manager of Central Sterile Processing Department, Unity Point Health, Des Moines, IA, Jan 2008 – May 2011. Responsible for comprehensive sterile processing services including the capital and operational budgeting acquisition, decontamination and safety management processes for inventory and supplies at several Unity Point Hospitals, OR and Inpatient Hospital Units, along with Outpatient and Ambulatory Clinic Services. Monitored and created Standard Operation Procedures for Sterilization Processes for surgical services, Lean Six-/Process Improvement Initiatives. Promoted regulatory compliance with International Association of Healthcare Central Service Material Management (IAHCSMM), International Conference of Harmonization (ICH), Federal Drug Administration (FDA), Good Manufacturing Practices (camp), and Good Clinical Practices (GCP). Prepared new product reports, proposals and grants, promoting the acquisition and utilization of most updated instrumentation adjustable workstations w/ultraviolet lights (for precise contaminate detection), Inventory Efficient Storage Bins, Concentrated Enzymatic Cleaners, Reprocessed Surgical Tools and other innovative products.

Volt Technical Services at Eli Lilly, Indianapolis, IN, August 2004 – October 2007. Supported Clinical Project Management team by coordinating daily activities associated with clinical trial development. Documented, synthesized, and reviewed data for the purpose of answering queries related to Standard Operating Procedures, Study Protocols, and Internal Board Reviews regulations for multiple clinical research trials. Managed Serious Adverse Events reporting process. Audited Study Binder forms including, Case Report Forms and Source Documents. Monitored Study Drug Accountability Logs, Reconciliation Reports, temperature logs and storage and transportation process.

Additional Work Related/Community Service Experience:

Iowa Heritage Home School Services), Des Moines, IA, Sept 2012 – August, 2018. Planned and implemented instructional goals, activities, and lessons with parents of home-school/independent study students.

Home Health Care Provider, Iowa Department of Human Services, Des Moines, IA, July, 2011- April 2015. Monitored and administered IV and oral prescription and over the counter drugs and performed daily patient assessments and personal care tasks.

Substitute Teacher (Intermittent), Wayne Township, Indianapolis, IN, Sept 2003- May 2007. Worked as a Certified Substitute Teacher primarily focusing on special need students grades K – 12th grades.

VOLUNTEER EXPERIENCE:

CONNECT COMMUNITY Service Project

Warriors For Life Sickle Cell Awareness Initiative



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