Kyersten Hoene
Fond du Lac,WI
Summary
Accomplished Senior Regulatory Specialist at the Medical College of Wisconsin, adept in regulatory compliance and clinical trial management. Proven track record in submitting complex applications and conducting risk assessments, ensuring adherence to GLP and GCP standards. Recognized for exceptional collaboration and training skills, enhancing operational efficiency and compliance across diverse research initiatives.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Senior Regulatory Specialist
Medical College Of Wisconsin-CTSI CTO
Milwaukee , WI
06.2022 - Current
- Submitted applications and amendments to regulatory agencies. This includes Emergency Use Applications, Expanded Access Protocols, and individual IND requests with the FDA.
- Performed monitoring duties on Investigator-Initiated Trials within the OB/GYN and Oncology departments.
- Conducted research into new or proposed regulations, laws, rules, as well as their implications on the organization's operations.
- Collaborated with internal stakeholders to develop corrective action plans for identified risks.
- Facilitated audits by coordinating with internal teams and external auditors as needed.
- Conducted risk assessments of current processes and procedures to identify areas of non-compliance.
- Provided training sessions for staff members on relevant topics such as legal and regulatory requirements.
- Evaluated operations to determine compliance with statutes.
- Assisted in the development of policies and procedures related to regulatory compliance initiatives. This includes the creation of SOPs, CAPAs, and Work Instructions.
- Maintained an up-to-date knowledge base of applicable federal, state, local, international laws and regulations pertaining to the organization's activities.
- Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
Clinical Research Coordinator III
Medical College of Wisconsin-CTSI CTO
Milwaukee, WI
02.2020 - 06.2022
- Worked directly with pediatric hematology and oncology, pediatric endocrinology, and pediatric AAI providers to facilitate clinical trials.
- Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Developed and maintained accurate and timely study databases.
- Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
- Developed case report forms for data collection at investigational sites.
- Provided training to study staff on protocol requirements and GCP regulations.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
Clinical Research Coordinator II
Medical College Of Wisconsin-CTSI CTO
Milwaukee, WI
04.2019 - 02.2020
- Worked directly with pediatric and adult dermatology providers to execute clinical trials.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
- Organized investigator meetings; developed meeting agendas; created presentations; tracked action items from meetings; coordinated follow-up communications after meetings.
- Developed and maintained accurate and timely study databases.
- Performed patient assessments, collected and analyzed data, and prepared reports.
- Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
- Developed case report forms for data collection at investigational sites.
Clinical Research Coordinator I
Medical College of WI-CTSI CTO
Milwaukee, WI
04.2018 - 04.2019
- Worked directly with cardiology, oncology, and gastroenterology providers to execute clinical trials.
- Performed patient assessments, collected and analyzed data, and prepared reports.
- Conducted routine visits to research sites to ensure compliance with protocol requirements.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Developed case report forms for data collection at investigational sites.
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Developed and maintained accurate and timely study databases.
- Completed submissions to the Institutional Review Board for clinical trials. Including initial submission, amendments, reportable events, continuing progress reports, and study close-out reports.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Conducted screening interviews to determine eligibility of possible subjects.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Collected, processed and delivered specimens from trial participants.
Clinical Research Coordinator
Spaulding Clinical Research
West Bend, WI
05.2015 - 02.2018
- Administratively and clinically manage an average of two to four Phase I clinical trials.
- Adhere to the CRO's SOPs.
- Adhere to Good Clinical Practices, and the study protocols.
- Ensure the scientific integrity of data, and protect the rights, safety, and well-being of patients enrolled in clinical trials.
- Collect, process, and ship blood and urine specimens at scheduled patient visits.
- Perform ECGs and obtain the vital signs of patients.
- Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy.
- Administer questionnaires and diaries per protocol.
- Ensure that non-serious and serious adverse events are properly documented and reported.
- Screen all laboratory results when received, and follow protocol procedures regarding abnormal results.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Overall trial oversight, from the date of study award through the final CSR.
Clinical Research Coordinator
Wisconsin Institute of Neurological Disorders
Milwauke, WI
01.2014 - 05.2015
- Administratively and clinically manage an average of six to eight clinical trials.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Kept patient care protocols and clinical trial operations in compliance.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
- Placed orders for medications to be used in studies.
- Developed case report forms for data collection at investigational sites.
- Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
Clinical Trial Associate
Wisconsin Institute of Neurologic Disorders
Milwaukee, WI
02.2012 - 01.2014
- To provide general administrative support to the Clinical Operations Department, and assistance to Project Manager(s) and Project Director(s).
- To be familiar with ICH GCP, appropriate regulations, relevant SOPs, and internal tracking systems.
- To be familiar with the roles of the Clinical Research Associates (CRA), including site visits, if appropriate.
- To set up, organize, and maintain clinical study documentation (e.g., Clinical Trial Master File, CRFs, etc.). Including preparation for internal/external audits, final reconciliation, and archival.
- To process Data Collection Forms, i.e., log in, tracking, and quality control, as appropriate for the study.
- To coordinate the ordering, dispatch, and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, and drug supplies, as appropriate.
- Collected, processed and delivered specimens from trial participants.
- Took vital signs and collected medical histories as part of study protocols.
- Performed reconciliation between source documents and database entries to ensure accuracy of information.
Education
Bachelor of Science - Psychology
Liberty University
Lynchburg, VA10-2025
Skills
- Regulatory compliance
- Clinical trial management
- Project management
- Auditing expertise
- Document control
- GLP and GCP compliance
Certification
- CITI Training April 2018-Current
Timeline
Senior Regulatory Specialist
Medical College Of Wisconsin-CTSI CTO
06.2022 - Current
Clinical Research Coordinator III
Medical College of Wisconsin-CTSI CTO
02.2020 - 06.2022
Clinical Research Coordinator II
Medical College Of Wisconsin-CTSI CTO
04.2019 - 02.2020
Clinical Research Coordinator I
Medical College of WI-CTSI CTO
04.2018 - 04.2019
Clinical Research Coordinator
Spaulding Clinical Research
05.2015 - 02.2018
Clinical Research Coordinator
Wisconsin Institute of Neurological Disorders
01.2014 - 05.2015
Clinical Trial Associate
Wisconsin Institute of Neurologic Disorders
02.2012 - 01.2014
Bachelor of Science - Psychology
Liberty University
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