BRADLEY GARY
Riverview,MI
Summary
Detail-oriented Clinical Research Professional well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.
Overview
13
13
years of professional experience
Work History
Senior Clinical Trial Coordinator
Profound Research
12.2023 - Current
- Conduct and manage all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements
- Mentor and train staff in the conduct of clinical trials, protocol requirements, communication and trial management skills
- Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up
- Ensure good documentation practices are applied by all team members when collecting, maintaining and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms
- Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors
- Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products.
Clinical Trial Lead
Topography Health Inc.
02.2021 - 11.2023
- Served as a lead coordinator at multiple sites around the USA to support the execution and monitoring of clinical studies and trial deliverables
- Assisted with recruitment efforts of trials at all sites
- Wrote and edited new SOPs, work instructions, and updates regulatory documents (e.g
- New informed consent forms) and clinically driven documents (e.g
- Visit checklists)
- Conducted training for new and existing staff members
- Was responsible for feasibility, implementation, planning, vendor management, project management, and study implementation of new trials across all company sites
- Worked with and closely managed multiple teams across many sites
- Conducted study visits, including blood draws and IP dispensation
- Conducted multi-site internal monitoring and quality checks of source data
- Assisted with construction of eSource and eRegulatory binders for all new studies
- Managed patient payments for clinical trial participation.
Clinical Research Coordinator
University of Pittsburgh Medical Center
07.2020 - 08.2021
- Lead and presented new studies for internal Site Initiation Visits (SIVs)
- Maintained regulatory documents up to Good Clinical Practice (GCP) standards
- Completed data entry and answered queries regarding all early experimental oncology trials
- Oversaw data management of all Phase 2 National Cancer Institute (NCI) clinical trials including research kit/biopsy collection
- Conducted study start-up, internal institutional review board submissions, and correspondence with all oncologists that serve as principal investigators of trials
- Chosen member of eRegulatory committee for new electronic systems trials management.
Clinical Research Coordinator
National Surgical Adjuvant Breast and Bowel Project, Inc. (NSABP)
08.2021 - 02.2021
- Primary study coordinator for multisite international clinical trials
- Appointed Drug Manager, oversaw all study drug management for all NSABP trials
- Maintained essential documents for clinical trials
- Corresponded with all sites to oversee monitor visits, amendments, staff training, and site compliance.
Clinical Research Coordinator
University of Michigan Hospital
03.2019 - 06.2020
- Practiced good GCP while managing over 20 clinical trials in breast and neurologic oncology
- Prescreened, screened, and enrolled patients in clinical trials
- Collected data, surveys, labs, research kits, and/or questionnaires
- Coordinated with patients to assure orders, infusions, prescriptions, appointments, and lab work are all correct and complete
- Implemented each protocol guideline until disease progression, study closure, or patient withdrawal.
Lab Manager
University of Michigan
02.2017 - 03.2019
- Performed data analysis on behavioral studies using iPython and assist with processing and analysis of neuroimaging (e.g., resting-state) data
- Practiced good clinical practice (GCP) with all human subjects that consented to research studies performed
- Consented human subjects in research studies and assisted in performing fMRI and transcranial magnetic stimulation (TMS) research protocols with said subjects
- Managed all correspondence with IRB amendments, continuing reviews, and protocol submissions
- Supervised and trained all undergraduate research assistants.
Research Study Coordinator
Department of Veterans Affairs Center of Excellence for Research on Returning War Veterans
02.2015 - 02.2017
- Served as primary preceptor for Neuroimaging student interns, supervising 8 students involved in different research opportunities
- Recruited, screened, consented, and conducted clinical and neuropsychological interviews with Veterans
- Corresponded with the IRB for protocol amendments, continuing review, and new protocol submissions
- Assisted in writing grant submissions (e.g., Human Subjects Form).
Research Project Manager
Baylor University's Texas Hunger Initiative
06.2014 - 01.2015
- Researched the implementation process of the Community Partner Recruitment Initiative through quantitative and qualitative analyses
- Set up and maintained data collection procedures and reporting tools to support internal and external reporting
- Created point-in-time surveys and administer them to the appropriate study sample.
Neuroscience Research Assistant
University of Texas Southwestern Medical Center
01.2013 - 05.2014
- Performed and completed experiments assigned by PI and interpreted results
- Cultured and plated hippocampal and cortical neurons from mice
- Maintained and bred multiple lines of transgenic, gene-specific, and wild-type mice for ongoing experiments
- Conducted quantitative real-time polymerase chain reaction, western blotting, cloning, viral transfection, and gel electrophoresis experiments
- Performed fear conditioning on gene-specific mice and collect and interpret these data.
Research Assistant
Texas A&M Health Science Center
11.2012 - 12.2012
- Created databases using SPSS software for use in data entry/analysis for self-report measures and clinically administered measures
- Modified current self-report forms for formatting and to accommodate for other research team requests.
Research Clerk
Department of Veterans Affairs Center of Excellence for Research on Returning War Veterans
06.2011 - 10.2012
- Performed administrative support duties including preparation of interviewer materials, administered follow-up questionnaires, and retention calls
- Conducted phone screens with veterans to determine initial study eligibility
- Explained and obtained Informed Consent Forms from participants and administered neuropsychological assessments.
Baylor Undergraduate Research Intern
Department of Veterans Affairs Center of Excellence for Research on Returning War Veterans
01.2011 - 06.2011
- Responsible for data entry and management
- Participated in weekly Diagnostic Review Group meetings culminating in a consensus on clinical interview diagnoses
- Conducted semi-structured phone interviews with firefighters assessing traumatic life events
- Assisted in establishing a training manual for future research.
Education
Bachelor of Science - Neuroscience
Baylor University
Waco, TX12.2012
Skills
- Site Management
- Research and Development
- Action Planning
- Coordinating Site Operations
- Patient Safety
- Protocol Adherence
- Interdepartmental Collaboration
- Completing Regulatory Documents
- Report Writing
- Quality Control
- Project Monitoring
- Recruitment Strategies
Languages
Spanish
Professional Working
Timeline
Senior Clinical Trial Coordinator
Profound Research
12.2023 - Current
Clinical Research Coordinator
National Surgical Adjuvant Breast and Bowel Project, Inc. (NSABP)
08.2021 - 02.2021
Clinical Trial Lead
Topography Health Inc.
02.2021 - 11.2023
Clinical Research Coordinator
University of Pittsburgh Medical Center
07.2020 - 08.2021
Clinical Research Coordinator
University of Michigan Hospital
03.2019 - 06.2020
Lab Manager
University of Michigan
02.2017 - 03.2019
Research Study Coordinator
Department of Veterans Affairs Center of Excellence for Research on Returning War Veterans
02.2015 - 02.2017
Research Project Manager
Baylor University's Texas Hunger Initiative
06.2014 - 01.2015
Neuroscience Research Assistant
University of Texas Southwestern Medical Center
01.2013 - 05.2014
Research Assistant
Texas A&M Health Science Center
11.2012 - 12.2012
Research Clerk
Department of Veterans Affairs Center of Excellence for Research on Returning War Veterans
06.2011 - 10.2012
Baylor Undergraduate Research Intern
Department of Veterans Affairs Center of Excellence for Research on Returning War Veterans
01.2011 - 06.2011
Bachelor of Science - Neuroscience
Baylor University