Microsoft Office 365
Years of Professional Experience
Kesi Michael
Research Manager
Rockville,MA
Summary
Experienced clinical research manager with extensive experience in patient-facing clinical and research roles, clinical data management, and project management. Currently, leading a team of research assistants in the facilitation of clinical care through genomic testing and the support of translational research including liquid biopsy, diagnostics, resistance mutations, treatment outcomes, and novel molecular marker identification.
Overview
11
11
3
3
Years of Management Experience
3
3
Publications
2
2
Leadership Positions
4
4
Certifications
Work History
Clinical Research Manager
Dana-Farber Cancer Institute
Boston, MA
09.2018 - Current
- Led team that oversees ordering, tracking, and reporting of clinical genomic testing used to direct patient care.
- Maintained multiple research databases with >10K patient records including, demographics, treatment, and genomic testing results.
- Oversaw numerous translational and genomic research projects resulting in publications.
- Evaluated employee skills and knowledge regularly, providing hands-on training and mentoring to individuals with lagging skills.
- Directed and supervised development, consent, screening, and regulatory aspects of translational research protocols.
Business Systems Analyst
The Ohio State's Wexner Medical Center
Columbus, OH
01.2017 - 08.2018
- Supported clinical research operations with study implementation, execution, billing, and reporting by collaborating with PIs and study teams.
- Delivered in-depth clinical trials management system training, imparting knowledge of best practices for protecting data and minimizing errors.
- Identified and outlined improvements including EMR integration and standardized CRFs to improved data quality and streamline workflows.
Clinical Research Coordinator
The Ohio State's Wexner Medical Center
Columbus, OH
09.2013 - 01.2017
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
Clinical Research Data Coordinator
The Ohio State's Wexner Medical Center
Columbus, OH
08.2011 - 08.2013
- Compiled data from patient records and questionnaires for various investigator-initiated, cooperative group, and industry clinical trials.
- Gathered and evaluated quality assurance data to identify issues and improve process efficiency.
- Cooperated with monitors and sponsors to assess data entry and eliminate errors.
Benefits Specialist
Columbus Neighborhood Health Center Inc.
Columbus, OH
10.2010 - 08.2011
- Assisted patients and families in accessing healthcare benefits provided through local, state, and federal programs.
- Provided outreach and access to healthcare for homeless and at-risk individuals within the community.
Junior Staff Scientist
CSS-Dynamac
Rockville, MD
11.2009 - 10.2010
- Coordinated meetings with CEOs and QA officers to collect data on food safety protocols.
Education
Bachelor of Science - Cellular And Molecular Biology
Kent State University
Kent, OH 08.2006 - 05.2009
Skills
Study protocols
Specimen collections
Research SOPs understanding
Informed consent
Medication dispensing
Good Clinical Practices
Trial management
Project Management
Teambuilding
Verbal and written communication
Data management
Collaboration
Organization and Time management
OnCore
Epic
REDCap
Certification
CITI: GCP for Clinical Research
Software
Microsoft Access
Redcap
Epic
OnCore
Adobe Creative Cloud
Sharepoint
Zoom
Microsoft Teams
Smartsheet
Slack
Jira
G Suite
Asana
Affiliations
The Parachute People (A 501 (c)(3) non-profit organization)
- Chairperson (March 2020 - Present)
Timeline
HIPAA Privacy and Security
08-2021
Clinical Research Manager
Dana-Farber Cancer Institute
09.2018 - Current
CITI: GCP for Clinical Research
09-2018
CITI: Biomedical and Social/Behavioral Combined HSP
09-2018
CITI: Biomedical Investigators and Key Personnel HSP
09-2018
Business Systems Analyst
The Ohio State's Wexner Medical Center
01.2017 - 08.2018
Clinical Research Coordinator
The Ohio State's Wexner Medical Center
09.2013 - 01.2017
Clinical Research Data Coordinator
The Ohio State's Wexner Medical Center
08.2011 - 08.2013
Benefits Specialist
Columbus Neighborhood Health Center Inc.
10.2010 - 08.2011
Junior Staff Scientist
CSS-Dynamac
11.2009 - 10.2010
Bachelor of Science - Cellular And Molecular Biology
Kent State University
08.2006 - 05.2009