Donald F. Cantrell, II

9154 Pershore PL

Tamarac, FL 33321

Day/Evening: (937) 260-3457

Cantrelldonald1@gmail.com

Education Kettering College of Medical Arts, Kettering, Ohio

2000-2004            Bachelor of Science, Health Science

Courses include: Nutrition, Bioethics, Introduction to Public Health, Statistics

Work Experience 

May 2017- University of Miami Sylvester Comprehensive Cancer Center, Miami, FL

Present Clinical Research Data Manager

Assist managing clinical trials for Thoracic and Precision Medicine Site Disease Groups 
Assist Monitors, Clinical research Coordinators and  Principal Investigators in the organization and preparation of Site Initiation Visits (SIV)
Attend site disease group tumor board meetings and site disease group collaborative meetings usually composed of PIs, sub-PIs, CRCs, IT, and Regulatory Staff 
Assist Clinical Research Coordinators ensuring that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner
Assist the PI in obtaining informed consent and documents the informed consent process as required.  Compiles patient data and presents those to the PI for their determination of patient eligibility for protocol enrollment 
Assist in the completion of protocol specific documents.  Obtain relevant medical information from patient clinic charts/medical records.  Maintain logs/progress reports to track both currently enrolled as well as follow-up participants
Provide protocol specific study documentation required in the management of study patient as per the protocol, federal regulations, and sponsor requirements and as required per UM policy
Under the supervision of the Principal Investigator.  Determine data to be collected and develop forms for collecting/summarizing data.  Enter data onto case report forms and/or into computer database as appropriate. Complete corrections/queries required at audits/monitor visits.  Ensure data integrity and consistency in computer database and written records
Assist the Clinical Study Coordinator with the entry of and maintenance of the patient calendar.  Ensure protocol specific data is entered into Velos
Enter data onto case report forms and/or into computer database. Completes corrections/queries required at audits/monitor visits in a timely manner. Ensures data integrity and consistency in computer database and written records by reviewing entered data for accuracy
Query data inconsistencies and revise case report forms in compliance with standard operating procedures, Institutional, Federal and Regulatory guidelines
Actively participates in monitoring visits/site audits, etc.  Seek review and approval of the Principal Investigator
Assist the Clinical Study Coordinator to maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs
Ensure that randomization and registration of patients are performed in compliance with CRS and UM policies, the protocol, ICH-GCP, and federal regulations
Provide support with study related procedures as required, i.e., EKG, laboratory and tumor assessment studies
Ensure work environment is organized and functions efficiently.  Participates in a collaborative, empowered work environment as demonstrated through teamwork.  Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center 
Participate in continuing education of research policies/guidelines.  Maintains professional growth and development through seminars, workshops, and professional affiliations to keep abreast of latest trends in field of expertise
Active member of CRS Quality Committee. Participate in the development of targeted department training specific to standardized clinical research procedures

August 2014 – DrugDev, Wayne, PA

April 2015 Clinical Data Analyst

Assisted in managing core financial data implementation for clinical trial contracts with Pharmaceutical Companies and Clinical Research Organizations
Assisted with establishing clinical study EDC data structure, ensuring integrity and compatibility of data upon entry into DrugDev’s systems 
Conducted clinical site and visit budget setup utilizing SAP, IPMS, and InSite 2.0 
Managed clinical site payment inquiries escalated for customer support, updating case management system appropriately
Participated in site closeout and reconciliation for study closeout
Reviewed clinical site enrollment data on an ongoing basis to ensure accuracy of payments to sites
Assisted in the preparation of monthly project status reports that are reviewed with clients during monthly project team meetings

May 2012 –  

October 2013                UPMC Cancer Center, Pittsburgh, PA

 Data Research Coordinator

Obtained medical records, laboratory, slides, radiology, and pathology reports of study participants, recording pertinent data into Medidata Rave for transmission to clinical trial sponsors
Assisted department nurses with the enrollment of potential clinical trial candidates based on designated 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
Presented study status update information during bi-weekly regulatory and safety meetings
Created study specific source documents and case report forms and study visit checklists 
Participated in data reconciliation and validation throughout the study life cycle for 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
Collaborated with multidisciplinary teams comprised of Gastrointestinal Oncology staff members, by supporting the collection and verification of information necessary for the management of clinical protocols 
Ensured the accuracy of CRFs by reviewing data prior to submission to study monitors
Simultaneously managed multiple clinical trials of varying size
Exercised knowledge of safety and compliance in accordance with GCP and ICH 

May 2008 –                     BioReliance, Rockville, Maryland

May 2012                        Associate Scientist I

Followed company and project SOPs relevant to compliance regulations, safety procedures, documentation, and scientific responsibility
Performed necropsies for histological and PCR collection
Performed QC reviews of GLP commercial study data
Presented research findings to study directors  
Trained new scientists and contractors regarding duties associated with the diagnostic laboratory
Prepared Helicobacter Pylori, Murine Norovirus, Hantavirus assays on small rodents for Clinical Pathology, Bacteriology, and Serology laboratories
Conducted electron microscopy tissue preparation and special staining procedures
Utilized knowledge of rodent and nonhuman primate parasitology for the purpose of reporting pathogenic and nonpathogenic information to biopharmaceutical companies
Maintained well organized study workbooks and stock solution batch records
Managed histological samples for GLP and Non-GLP studies

February 2007- Proctor & Gamble/Adecco Staffing, Cincinnati, Ohio

April 2008 Laboratory Technician 

Worked in the product research and development division of the Surface Care Department for the Swiffer® brand label and assisted with the prototyping of new products
Worked collaboratively with Product Engineers and Staff Scientists on the research, development, and technical testing for all Swiffer dry mop products
Obtained scientific data to monitor the performance of new products as well as integrated the knowledge of variables associated with performance testing and had the ability to interpret the results

Skills:

Proficient in Microsoft Office Suite, CTMA, Medidata Rave, AGMednet, Provantis, Epic

Hyperspace, SAP Business One, Salesforce, IPMS, InSite2.0

Interests:

Reading, science, art, politics, music, traveling