Clinical Trial Practice
Resume:
Shirley Tobler
Apt E
Greensboro, NC 20406
GOOD CLINICAL PRACTICE TRAINING
CITI Good Clinical Practice completed 25 October 2023 EDUCATION
****-****(6mos.) Certificate earned in Accounting Brookstone Business College Greensboro, NC
1995-1995(6mos) Certificate earned in Medical and Office Procedures Brookstone Business College Greensboro, NC
EMPLOYMENT
10/2023-present Healthcare Data & Regulatory Compliance Coordinator; Triad Clinical Trials LLC Carefully analyzing, transferring and inputting data Greensboro, NC from paper documents. Ensuring compliance with all applicable regulations and IRB requirements. Assisting with maintaining ISF, clinical trials and other office work. 08/2021-09/2023 Clinical Trial Administrator; LabCorp/Covance/Fortrea Document and track study activities using relevant Greensboro, NC Forms and tools, as well as relevant Project Management Systems with minimal guidance and support. Assist in the Preparation of study and site-specific materials in accordance with relevant SOPs. Complete minute taking and documentation for sponsor external or internal teleconferences as requested. Create and maintain tracking systems/spreadsheets for e.g. study supplies. Provide support to project team (e.g., proof-reading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.) Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and archive as applicable. Set up and maintain clinical investigator files and documentations. Work with the In-House Clinical Research Coordinators and other project team members on reconciliation of data with the Clinical Trial Management System. Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead. Train and mentor less experienced Clinical Trial Administrators.
04/2019-12/2022 Research Regulatory Coordinator; Florida Cancer Specialist Prepared and submitted regulatory documents for all Fort Myers, FL Submissions. Prepared and maintained safety reports Developed appropriate regulatory reports and associated Documentation parameters of my fiduciary duties.
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02/2016-03/2022 Administrative Assistant; Clark Group/FCPH Handled office tasks, such as filing, generating Winston Salem, NC reports and presentation, setting up for meetings
and reordering supplies. Received Risk Screening
forms. Entered the data into the Care Management
Information System. Sent referrals to Baby Love
Program and Natural Family Program
08/2007-10/2016 Clinical Research Coordinator/Rater Guilford Neurologic Associates Coordinated elements of a clinical trial study related visits Greensboro, NC Maintained Investigational Product accountability. Maintained Regulatory maintenance. Maintained Source documentation and source creation. Entered data into the Electronic Data Capture system. Completed Case Report Form, Adverse Event, Serious Adverse Events Completed query resolution Prepared for monitoring visit. Collected, processed and shipped of lab samples. Did neurological assessments on patients
Business References
• Wesley Harbison
Field Reimbursement Manager
*********@*******.***
• Brittney Johnson
Research Regulatory Coordinator
*************@******.***
• Patricia Henderson
Director of Clinical Operations
********.************@*****.***
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