Donald F. Cantrell, II
Sunrise
Summary
Dynamic clinical research professional with extensive experience in leading complex trials and ensuring regulatory compliance. Proven track record in enhancing patient enrollment strategies and coordinating cross-functional teams to meet study goals. Committed to advancing organizational objectives through innovative problem-solving and effective communication.
Overview
18
18
years of professional experience
Work History
Clinical Trial Lead
Yanuvia
Boca Raton
09.2025 - 04.2026
- Acted as the primary point of contact between sponsors, investigators, site staff, and cross-functional teams.
- Ensured all studies met intended goals while adhering strictly to study protocols and regulatory requirements.
- Oversaw recruitment, enrollment, and retention strategies to support robust study enrollment.
- During study start-up, provided virtual training sessions to research naïve and experienced sites' research staff, ensuring they had the necessary access to company systems and study source-related materials to meet the trial goals.
- Acted as an ongoing resource for sites, addressing trial-related questions and ensuring timely replenishment of necessary trial resources.
- Led monthly Study Coordinator Virtual Meetings to provide trial status updates, discuss common trends and best practices, and facilitate an open forum for enhancing patient enrollment strategies.
- Participated in weekly and bi-weekly meetings with sponsors to review timely and accurate data entry, and maintained official paperwork based on the Trial Master File (TMF).
- Coordinated procurement, ordering, and shipment of medical supplies and trial materials for all Yanuvia trial sites.
- Resolved queries in the EDC and image portal systems for colorectal screening and lung trials
- Sent weekly encouragement emails to sites to assist with bolstering patient enrollment
Clinical Research Coordinator 2
University of Miami Sylvester Comprehensive Cancer Center
Miami
10.2021 - 01.2025
- Coordinated routine activities for clinical studies, including data maintenance, adherence to grant expenditures, project evaluation, meeting scheduling, and interfacing with research subjects.
- Tracked medical reports and reviewed regulatory documents to generate reports.
- Served as project liaison to other departments, outside organizations, government agencies, and product representatives.
- Devised Smartset orders in EPIC for assigned clinical trial-related treatment plans.
- Scheduled training sessions featuring the PI and the Research Nurses to review the administration of the treatment drugs and how to treat expected Adverse Events.
- Demonstrated sound leadership qualities through chairing monthly virtual oversight meetings for Principal Investigators of both the Thoracic and Head and Neck Groups to discuss clinical trial-related matters.
- Recruited patients for Thoracic and Head and Neck clinical trials and reviewed the weekly percentage recruited.
- Educated subjects and family members regarding specific studies and clinical drug trials in general.
- Coordinated the procurement of pathological samples between internal departments and external facilities for histological processing to be submitted to the sponsor during protocol-specific timepoints.
- Assisted with study orientation and protocol-related in-services to the research team and clinical staff.
- Reviewed and entered data into study datasets and uploaded radiological images to sponsor-designated imaging systems or portals.
- Evaluated and monitored study timelines and ensured each subject participant complied with applicable protocols.
- Assisted with Sponsor Site Initiation Visits to ensure the clinical team had the appropriate vendor access for clinical trial activities
- Administered informed consent forms for patients on drug studies.
- Coordinated the necessary testing for patient evaluations per physicians' orders and study protocol requirements.
Clinical Data Research Manager
University of Miami Sylvester Comprehensive Cancer Center
Miami
05.2017 - 10.2021
- Assisted in managing clinical trials for Thoracic and Precision Medicine Site Disease Groups
- Assisted Monitors, Clinical Research Coordinators and Principal Investigators in the organization and preparation of Site Initiation Visits (SIV)
- Attended site disease group tumor board meetings and site disease group collaborative meetings, notably composed of PIs, sub-PIs, CRCs, IT, and Regulatory Staff
- Assisted Clinical Research Coordinators ensuring that all protocol revisions, informed consents, continuing reviews, and serious adverse events are submitted to the appropriate IRB of record promptly
- Assisted the PI in obtaining informed consent and documented the informed consent process as required. Compiled patient data and presented those to the PI for their determination of patient eligibility for protocol enrollment
- Assisted in the completion of protocol-specific documents. Obtained relevant medical information from patient clinic charts/medical records. Maintained logs/progress reports to track both currently enrolled and in survival follow-up
- Provided protocol-specific study documentation required in the management of study patients as per the protocol, federal regulations, and sponsor requirements, and as required per UM policy
- Under the supervision of the Principal Investigator, collected and developed forms for collecting/summarizing data. Entered data onto case report forms and/or into computer databases as appropriate. Completed corrections/queries required at audits/monitoring visits. Ensured data integrity and consistency in computer databases and written records for accuracy
- Assisted the Clinical Study Coordinator with the entry of and maintenance of the patient calendar. Ensured protocol-specific data is entered into Velos
- Entered data onto case report forms and/or into computer databases. Completed corrections/queries required at audits/monitor visits promptly. Ensured data integrity and consistency within the computer database and written records by reviewing entered data for accuracy
- Reviewed query data inconsistencies and revised case report forms in compliance with standard operating procedures, Institutional, Federal and Regulatory guidelines
- Actively participated in monitoring visits/site audits, etc. Sought the review and approval of the Principal Investigator
- Assisted the Clinical Study Coordinator in maintaining screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol-specific logs
- Ensured that randomization and registration of patients were performed in compliance with Clinical Research Services (CRS) and UM policies, the protocol, ICH-GCP, and federal regulations
- Provided support with study-related procedures as required, i.e., EKG, laboratory and tumor assessment studies
- Ensured the work environment was organized and functioned efficiently. Participated in a collaborative, empowered work environment as demonstrated through teamwork.
- Demonstrated a level of professional practice that supported the delivery of appropriate care which contributed to positive working relationships throughout the medical center
- Participated in continuing education on research policies/guidelines. Maintained professional growth and development through seminars, workshops, and professional affiliations to keep abreast of the latest trends of the Clinical Research industry
- Member of the CRS Quality Committee. Participated in the development of targeted department training specific to standardized clinical research procedures
Clinical Data Analyst
DrugDev
Wayne
08.2014 - 04.2015
- Managed core financial data implementation for clinical trial contracts with pharmaceutical companies and clinical research organizations by establishing clinical study EDC data structure, ensuring data integrity and compatibility upon entry into DrugDev's systems
- Conducted clinical site and visit budget setup using SAP, IPMS, and InSite 2.0, facilitating accurate financial tracking for clinical trials
- Reviewed clinical site enrollment data regularly to verify payment accuracy for sites, contributing to timely and correct financial transactions
- Managed clinical site payment inquiries escalated for customer support, and updated case management systems appropriately
- Participated in site closeout and reconciliation for study closeout
- Assisted in the preparation of monthly project status reports that are reviewed with clients during monthly project team meetings
Data Research Coordinator
UPMC Cancer Center
Pittsburgh
05.2012 - 10.2013
- Obtained medical records, laboratory, slides, radiology, and pathology reports of study participants, recording pertinent data into Medidata Rave for transmission to clinical trial sponsors
- Supported enrollment of clinical trial candidates by collaborating with nursing staff to apply study inclusion and exclusion criteria
- Assisted in the coordination of initiation, site evaluation, monitoring visits and audits required by the sponsor
- Used Clinical Trials Management Application (CTMA) to enter subject trial registration and study status updates
- Familiarity with managing ECOG and other cooperative group trials
- Delivered study status updates during bi-weekly regulatory and safety meetings to enhance communication and oversight
- Created study specific source documents and case report forms and study visit checklists
- Conducted data reconciliation and validation throughout study life cycle to ensure accurate reporting of central and local laboratory results, including AEs, SAEs, and biomarkers
- Utilized AGMednet by loading and validating radiological scans and biomarker information prior to review by third-party vendors
Associate Scientist I
BioReliance
Rockville
05.2008 - 05.2012
- Followed company and project SOPs relevant to compliance regulations, safety procedures, documentation, and scientific responsibility
- Prepared Helicobacter Pylori, Murine Norovirus, Hantavirus assays on small rodents for Clinical Pathology, Bacteriology, and Serology laboratories
- Conducted necropsies to facilitate histological analysis and PCR collection
- Managed histological samples for GLP and Non-GLP studies
- Performed QC reviews of GLP commercial study data
- Presented research findings to study directors to inform project decisions
- Trained new scientists and contractors on diagnostic laboratory duties to ensure compliance and operational efficiency
- Conducted electron microscopy tissue preparation and special staining procedures
- Utilized knowledge of rodent and nonhuman primate parasitology to report pathogenic and nonpathogenic information to biopharmaceutical companies
- Maintained well-organized study workbooks and stock solution batch records
Education
Bachelor of Science - Health Science
Kettering College of Medical Arts
Kettering, Ohio05-2004
Associate of Science - Health Sciences
Oakwood University
Huntsville, AL04-2000
Skills
- Clinical trial management systems (CTMS)
- Medidata Rave
- REDCap
- TrialMaster
- Medrio
- AGMedNet
- Microsoft Office Suite
- Google Sheets
- Data analysis
- Salesforce
- Regulatory compliance
- Epic Hyperspace
- Interpersonal and communication skills
- Salesforce
Hobbies and Interests
- Reading
- Science
- Art
- Health and Wellness
- Music
- Traveling
Timeline
Clinical Trial Lead
Yanuvia
09.2025 - 04.2026
Clinical Research Coordinator 2
University of Miami Sylvester Comprehensive Cancer Center
10.2021 - 01.2025
Clinical Data Research Manager
University of Miami Sylvester Comprehensive Cancer Center
05.2017 - 10.2021
Clinical Data Analyst
DrugDev
08.2014 - 04.2015
Data Research Coordinator
UPMC Cancer Center
05.2012 - 10.2013
Associate Scientist I
BioReliance
05.2008 - 05.2012
Bachelor of Science - Health Science
Kettering College of Medical Arts
Associate of Science - Health Sciences
Oakwood University