Lisa Schmid
Cincinnati,OH
Summary
Goal setting highly organized, research professional with exceptional interpersonal and communication skills. Research experience crosses a wide range of duties including but not limited to clinical monitoring, site validation, protocol implementation and compliance, patient enrollment, team management, collaboration with clinical study team, and communication with site, CRO and sponsor representatives. Therapeutic experience focused solely in Oncology, inclusive of phase I, solid tumor malignancies, hematologic malignancies, immunotherapeutic agents and targeted therapies.
Overview
9
9
years of professional experience
Work History
Senior Clinical Trial Manager
IQVIA BIOTECH
05.2021 - Current
- Serves as client advocate for IQVIA BIOTECH
- Develops, maintains, and implements clinical monitoring plans, deviation management plans and cohort management plans
- Responsible for assuring needs of clinical sites are met by facilitating all clinical monitoring processes
- Coordinates, oversees, and conducts daily operations of clinical monitoring including but not limited to data entry, data review, data verification, subject tracking, sample tracking, regulatory compliance, protocol compliance, report review, report compliance
- Manages Projects milestones and proactively addresses deficiencies
- Manages clinical research associate performance
- Assists project manager with review of project budgets, monitoring costs and overruns
- Participates in Bid Defense process and presentation
Clinical Research Associate
PRA Health Sciences
11.2020 - 05.2021
- Worked closely with clinical team members to facilitate timely resolution of trial and/or clinical issues
- Provided frequent site statues information to team members and trial management
- Reviewed and verified accuracy of clinical trial data collected, either onsite or remotely
- Assessed qualifications of potential investigative sites, initiated clinical trials at investigative sites, and closed out trials at investigative sites
- Instructed site personnel on the proper conduct of clinical trials
- Performed essential document site file reconciliation
- Facilitated audits and audit resolution
- Implemented and monitored clinical trials to ensure sponsor and investigator obligations were being met and compliant with applicable local regulatory requirements
Clinical Research Manager
University of Cincinnati Cancer Institute
07.2019 - 11.2020
- Responsible to direct oversite of 12 Clinical Research Professionals
- Oversaw day to day practice of clinical research within the academic center
- Performed site feasibility for study start-up
- Attended and coordinated research specific disease site meetings (Phase I experimental therapeutics, Brain, GU, GI, and Skin cancers)
- Wrote and updated Standard Operating Procedures
- Implemented and updated cancer center policies, workflows, and guidelines
- Member of Process Improvement Committee
- Member of Investigator Initiated Trial Committee Phase I Team
Lead Senior Clinical Research Coordinator
University Of Cincinnati
03.2018 - 06.2019
- Responsible for pre-screening, screening, enrolling, and monitoring study patients for industry-sponsored Phase I Oncology clinical trials in numerous oncologic therapeutic areas
- Served as liaison between primary investigators and sponsoring organizations representatives
- Scheduled and conducted Site Initiation Visits (SIVs) and Interim Monitoring Visits (IMVs)
- Maintained adherence to CGP and FDA guidelines
- Attended tumor boards with local Oncologists/Hematologists in order to assist with identification of potential research subjects
- Oversaw Phase 1 team employees
- Assisted with study start up activities including feasibility, budget review and site-level planning for specific projects
- Communicated with CRO and Sponsor representatives in order to maintain effective working relationships and execute projects as specified by protocols
Clinical Research Coordinator II
Oncology Hematology Care, Inc
03.2014 - 03.2018
- Executed clinical research for Oncology/Hematology sponsored studies phase I- IV according to GCP, obtain informed consent, perform pre-screening/screening activities, collect subject data, process laboratory specimens.
- Managed oral drug accountability for study subjects.
- Participated in Site Initiation Visits (SIVs) and Interim Monitoring Visits (IMVs)
- Collaborated with physicians, radiologists, treatment nurses, medical assistants and office staff in order to provide organized, comfortable experiences for all patients while utilizing best practice.
- Effectively communicated with research team, including site monitors, regulatory, data management and principal investigator
- Collected data and followed research protocols, operations manuals, and case report form requirements.
Education
Associates Degree - Nursing
Galen College of Nursing
Cincinnati, OH04.2010
Bachelor of Science - Nursing
Ohio University
Athens, OH2017
Skills
- Study Monitoring
- Activity Monitoring
- Clinical Trial Management
- Good Clinical Practice
- Phase I Oncology
- Data Review
- Data Verification
- Electronic Data Systems
Additional Information
- Licensure and Certifications, State of Ohio- License Number RN.364391
Timeline
Senior Clinical Trial Manager
IQVIA BIOTECH
05.2021 - Current
Clinical Research Associate
PRA Health Sciences
11.2020 - 05.2021
Clinical Research Manager
University of Cincinnati Cancer Institute
07.2019 - 11.2020
Lead Senior Clinical Research Coordinator
University Of Cincinnati
03.2018 - 06.2019
Clinical Research Coordinator II
Oncology Hematology Care, Inc
03.2014 - 03.2018
Associates Degree - Nursing
Galen College of Nursing
Bachelor of Science - Nursing
Ohio University
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