Michelle Jewett
Lenexa,KS
Summary
With over eight years of experience in clinical research and operations, I am a passionate and dedicated leader in the field of cancer care. As the Clinical Operations Manager at the University of Kansas Cancer Center, I oversee the daily operations of the clinical research staff, ensuring adherence to protocols, regulations, and quality standards. I hold a CCRC certification from the Association of Clinical Research Professionals, demonstrating my competence and commitment to the profession. I have also contributed to multiple clinical trials and studies, working with diverse teams and stakeholders, and supporting the mission of advancing cancer prevention, diagnosis, and treatment. I am driven by the values of excellence, integrity, and innovation, and I strive to create a positive and collaborative work environment for my team and the organization. I am excited to continue to learn, grow, and make a difference in the field of cancer research and operations.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Clinical Operations Manager
University of Kansas Cancer Center
05.2022 - Current
- Oversee day-to-day operations for seven Clinical Research Coordinators to ensure clinical coverage across four satellite sites and to triage clinical concerns and research coordinator issues
- Evaluate resources to ensure equitable workload distribution and ensure processes are consistent
- Develop direct reports through initial on-board training, regular 1:1 mentoring and coaching, career path management, leave requests, continuing education, and delegation of responsibility
- Serve as expert mentor to junior staff
- Establish and assign the activities of multiple teams to accomplish study goals
- Assess feasibility of protocols, including appropriate patient population and specific needs for the study
- Coordinate and communicate with sponsor, CRO, and ancillary research departments and organizations involved in the day- to- day study and program management
- Monitor observance of departmental operational policies and guidelines.
- Regularly evaluate employee performance and provide feedback.
Senior Clinical Research Coordinator
University of Kansas Cancer Center
12.2020 - 05.2022
- Under the direction of the Principal Investigator, recruit and educate potential patients and evaluate potential patient eligibility for Phase II and III solid and liquid tumor clinical trials
- Served as the lead study coordinator on multiple clinical trials and as a mentor for junior staff
- Responsible for working collaboratively with multidisciplinary teams, research, and hospital staff to assist in the overall coordination of oncology clinical trials
- Perform study procedures as outlined in the protocol within the institutional scope of practice
- Provides clear comprehensive documentation of study procedures and visits and assists in the identification and reporting of adverse and serious adverse events in accordance with ICH/CRF/GCP and study protocols
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Demonstrated ability and flexibility in working at multiple clinic sites as needed to meet research department staffing needs
Clinical Research Coordinator
University of Kansas Cancer Center
04.2017 - 12.2020
- Clinical coordination of numerous Phase II and III trials for solid tumor and hematologic diseases
- Responsible for working collaboratively with multidisciplinary teams, research, and hospital staff to screen, educate, and assist in the overall coordination of oncology clinical trials
- Responsible for communication regarding patient care, status and protocol requirements with collaborating hospital and research staff
- Provides clear comprehensive documentation of study procedures and visits and assists in the identification and reporting of adverse and serious adverse events in accordance with ICH/CRF/GCP and study protocols
- Demonstrated ability and flexibility in working at multiple clinic sites as needed to meet research department staffing needs.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Clinical Data Coordinator
University of Kansas Cancer Center
02.2016 - 04.2017
- Responsible for working collaboratively with Clinical Research Coordinators in the coordination and collection of data for cancer clinical trials
- Responsible for the collection, abstraction, review, documentation, and monitoring of data related to clinical research projects
- Research and resolve data discrepancies; coordinate final database closure activities and participate in customer audits and process improvement initiatives
- Assist with the identification and reporting of Adverse and Serious Adverse events in accordance with ICH/CFR/GCP and clinical trial protocols.
Clinical Research Coordinator
University of Kansas Medical Center – Kidney Institute
07.2014 - 02.2016
- Completion of assigned research protocols, including patient recruitment and enrollment, organization of study visits, data collection, and all required reporting
- Assist in grant administration, including monitoring of study accounts, submitting requisitions for payments from study accounts, and coordinating with sponsored programs to manage financial aspects of clinical trials
- Responsible for administrative activities in support of clinical research within the Kidney Institute
Administrative Assistant
University Of Kansas Medical Center
02.2013 - 06.2014
- Assisted faculty and research personnel with the preparation and submission of grant applications and annual reports in coordination with the Research Institute
- Provided clerical support and assistance with monthly financial report reconciliations for the Administrative Director
- Developed and maintained a database of submitted and funded grant projects and identified funding opportunities for faculty and research personnel
Specimen Management Associate
Quintiles
08.2011 - 01.2013
- Managed laboratory processing procedures for numerous phase I clinical trials and adhered to clinical trial protocols and IRB regulations
- Processed samples for storage, onward shipping or laboratory testing in an accurate and timely manner as required by each clinical trial protocol
- Performed quality control checks on collected data in order to ensure accuracy
Education
Bachelor of Science - Biology, Cell Biology
University of Kansas
Lawrence, KSSkills
- Strong analytical, organizational, and communication skills
- Detail-oriented, self-motivated, and demonstrated ability to multi-task
- Effective in problem-solving, conflict resolution, relationship-building, and staff development
- Proficient in Microsoft Office and various CTMS, IRT, and EDC systems
- Working knowledge of GCP, FDA and ICH guidelines
- Strong oncology experience in multiple therapeutic areas
Certification
ACRP Certified Clinical Research Coordinator - October 19, 2020 – present
Timeline
Clinical Operations Manager
University of Kansas Cancer Center
05.2022 - Current
Senior Clinical Research Coordinator
University of Kansas Cancer Center
12.2020 - 05.2022
Clinical Research Coordinator
University of Kansas Cancer Center
04.2017 - 12.2020
Clinical Data Coordinator
University of Kansas Cancer Center
02.2016 - 04.2017
Clinical Research Coordinator
University of Kansas Medical Center – Kidney Institute
07.2014 - 02.2016
Administrative Assistant
University Of Kansas Medical Center
02.2013 - 06.2014
Specimen Management Associate
Quintiles
08.2011 - 01.2013
Bachelor of Science - Biology, Cell Biology
University of Kansas
ACRP Certified Clinical Research Coordinator - October 19, 2020 – present
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