Jessica Wewer
Lead Clinical Research Coordinator at KANSAS GASTROENTEROLOGY LLC- Claim this Profile
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Bio
Credentials
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FDA Regulated Research
CITI ProgramApr, 2022- Nov, 2024 -
UCLA HIPAA
CITI ProgramApr, 2022- Nov, 2024 -
Trial Feasibility and Selection: Thier Impact on Accrual
ACRP - Association of Clinical Research ProfessionalsMar, 2022- Nov, 2024 -
Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA
ACRP - Association of Clinical Research ProfessionalsFeb, 2022- Nov, 2024 -
Form FDA 1572: Get it Right the First Time
ACRP - Association of Clinical Research ProfessionalsFeb, 2022- Nov, 2024 -
Improving Recruitment Rentetion and Accrual in Clinical Trials
ACRP - Association of Clinical Research ProfessionalsFeb, 2022- Nov, 2024 -
Inspection Readiness: Best Practices for Managing Clinical Trial Inspections
ACRP - Association of Clinical Research ProfessionalsFeb, 2022- Nov, 2024 -
Key Skills for Ensuring Quality Control
ACRP - Association of Clinical Research ProfessionalsFeb, 2022- Nov, 2024 -
Risk Based Monitoring: The Essentials
ACRP - Association of Clinical Research ProfessionalsFeb, 2022- Nov, 2024 -
Site Quality Management Tools
ACRP - Association of Clinical Research ProfessionalsFeb, 2022- Nov, 2024 -
HIPPA
Healthcare Compliance ProsDec, 2021- Nov, 2024 -
Group 1: Good Clinical Practice (GCP) for Biomedical Researchers and Research Staff
CITI ProgramApr, 2022- Nov, 2024 -
Group 1: Human Subjects Research
CITI ProgramDec, 2021- Nov, 2024
Experience
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Kansas Gastroenterology, LLC
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United States
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Medical Practices
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1 - 100 Employee
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Lead Clinical Research Coordinator
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Aug 2022 - Present
• Protocol implementation: Assisting with the execution of study protocols and ensuring that study objectives and timelines are met. • Patient recruitment: Identifying potential study participants, conducting pre-screening evaluations, and ensuring that the participant eligibility criteria are met. • Study management: Overseeing the day-to-day operations of the study, including scheduling appointments, collecting and monitoring study data, and maintaining accurate and up-to-date study records. • Data management: Ensuring the accuracy and completeness of study data, including medical histories, laboratory results, and study-specific information. • Regulatory compliance: Ensuring that the study complies with all relevant federal, state, and local regulations, as well as with institutional review board (IRB) requirements. • Budget management: Managing the study budget, including tracking expenses and preparing financial reports. • Site management: Overseeing the performance of study sites, including the training of site personnel and monitoring site compliance with study protocols • Collaboration: Collaborating with other members of the study team, including investigators, study sponsors, and IRB personnel. Show less
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Cancer Center of Kansas
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Medical Practices
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1 - 100 Employee
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Lead Regulatory Project Manager - Oncology
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Jun 2022 - Jul 2022
Manage regulatory documents in all stages of the clinical trial o Manage multiple data-gathering efforts o FDFs, FDA 1572, ICF etc. o Manage upwards of 75 active protocols & upwards of 35 trials in the start-up phase • Oversee central and local IRB submissions, approvals etc. • Pharmacovigilance delegated liaison • Delegate IRB approved items which require staff training o Site training: SOP, protocols, IBs, GCP etc. Maintain employee training database Created a training portal for study specific IB and protocol training Show less
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Regulatory Specialist
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Dec 2021 - Jun 2022
• Familiar with central and local IRB systems• Work with multiple CROs • Site training: SOP, protocols, IBs, GCP etc. • Maintain employee training database • Streamlined clinical trial trainings• Decrease paper waste by implementing electronic training • Created a training portal for study specific IB and protocol training • Documentation retention & electronic filing management• Oversee upwards of 76 active protocols• Oversee upwards of 35 trials in start-up • Familiar with GCP, HIPPA and FDA guidance for IND trials• Compliance management • Manage multiple data-gathering efforts • Clinical trial oversight & management• Start-up procedures consistent with FDA & IRB guidelines• FDFs, FDA 1572 etc. • Pharmacovigilance delegated liaison Show less
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Xpress Wellness Urgent Care
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United States
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Medical Practices
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1 - 100 Employee
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Clinical Liaison
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Feb 2021 - Dec 2021
• Respond to patient referrals • Clinical Documentation Improvement • Process payer information & ensure requirements are met • Assist with scheduling appointments or treatment • Coordinate patient discharges and transfers • Respond to patient referrals • Clinical Documentation Improvement • Process payer information & ensure requirements are met • Assist with scheduling appointments or treatment • Coordinate patient discharges and transfers
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Wesley Healthcare
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United States
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Hospitals and Health Care
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700 & Above Employee
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Audiology Assistant per diem
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2019 - 2020
Newborn hearing screening Newborn hearing screening
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Wichita State University
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United States
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Higher Education
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700 & Above Employee
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Research Assistant
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2017 - 2020
• Study and site management of on campus laboratories • Generation of informed consent documents • Equipment & vendor management • Safety & Ethics Liaison • Developed Good Clinical Practice training bootcamp for both undergraduate & graduate students. • Assist professors and students with research design and concepts • Data review & verification • Project timelines • Completed IRB submissions • Study and site management of on campus laboratories • Generation of informed consent documents • Equipment & vendor management • Safety & Ethics Liaison • Developed Good Clinical Practice training bootcamp for both undergraduate & graduate students. • Assist professors and students with research design and concepts • Data review & verification • Project timelines • Completed IRB submissions
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Education
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2018 - 2020
Wichita State University
Doctor of Audiology -
2016 - 2018
Wichita State University
Bachelor of Arts - BA, Communication Sciences and Disorders, General
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