Carla Rothacker
Tampa
Summary
Apply the skills learned working as a Senior Regulatory Coordinator to enhance the effectiveness of Clinical Trials.
Overview
13
13
years of professional experience
Work History
Senior Regulatory Coordinator
CenExel ForCare Clinical Research
10.2022 - Current
- In addition to the Regulatory Coordinator’s role: Serves as an expert resource for teammates.
- Oversees the creation of Investigator Site Files from Pre-Study to close-out.
- Main point of contact during Study-Start Up.
- Oversees the progress of Study Start-Up activities, ensuring the site meets all timelines and is compliant with all regulatory regulations.
Regulatory Coordinator
CenExel ForCare Clinical Research
07.2022 - 10.2022
- Responsible for preparing and submitting Study Start-Up Regulatory Packages to Sponsor and the IRB
- Coordinates and communicates with the IRB, Pharmaceutical Sponsor, and Clinical Research Organizations (CROs)
- Tracks study approvals and expirations to ensure compliance with the Institutional Review Board (IRB)
- Maintain regulatory e-ISF (RealTime) binders and paper ISF binders to ensure all regulatory-related documents are up to date
- Maintain and track current Informed consent forms to ensure accurate use by the clinical coordinators
- Submits various applications and reports to the IRB including but not limited to continuing review reports, termination reports, protocol deviation reports, and modification submission forms
- Coordinates with study sponsor, investigator, and IRB to complete study closure activities
- Assists with process and policy issues and guides form preparation and submission
- Maintains current knowledge of federal, state, and institutional guidelines and requirements governing research
- Maintain current documents for research staff, e.g., CVs, licenses, certifications, training, and development of CVs for new personnel
- Oversee staff training and certifications to ensure compliance with standard operating procedures (SOPs), regulations, and protocol requirements
- Responsible for scheduling on-site visits and assisting with the coordination of Site Initiation Visits.
Regulatory Coordinator
Stedman Clinical Trials
04.2021 - 07.2022
- Conducted sponsored clinical trials from pre-study preparation through closeout visits following FDA regulations and GCP guidelines as well as assisting site staff with regulatory compliance
- Comply with all SOPs and QC systems
- Ensure completion of start-up packages including: FQ, CDAs (CTAs), FDA 1572, FDFs, Submission of the Investigator Application, Reviewing Existing Protocols, Investigator Brochure’s, ICF Templates
- Create, maintain, and accurately file all regulatory documents and necessary logs within the regulatory binder(s) and in the site’s S drive
- Maintain and communicate current documentation for all research staff e.g., CVs, Licenses, certifications (GCP, IATA, etc..,) and training
- Provide documentation to Sponsors/CROs upon request
- Create spreadsheets to track regulatory documents before expiration
- Complete continuing review and close-out documentation to the IRB
- Additional duties include: Participating in educational and training activities
- Monitoring and taking vitals of Spravato patients for two hours.
Certified Clinical Hemodialysis Technician/Vascular Access Manager
DaVita Dialysis Clinic
07.2019 - 04.2021
- Ensure the comfort and safety of all patients in the dialysis center before, during, and after the dialysis treatment
- Weigh the patient, take vitals (temperature, blood pressure, heart rate, and if applicable blood sugar), and monitor vascular accesses, pre- and post-dialysis
- Administer fluid therapy under the direction of the RN
- Draw blood multiple times a month as well as blood draws for transplant labs if required
- Review and document dialysis orders, observe the physical and mental condition of patients, interview each patient for any new complications since their last dialysis treatment, and provide feedback to determine compliance with dietary and/or medical regimens
- Strict adherence to safety protocols for all dialysis equipment
- Provide each patient and family member with different types of education monthly.
ER Scribe
ScribeAmerica
07.2016 - 07.2019
- Assisting with the flow of patients by documenting HPI, past medical history, the physical exam, vital signs, procedures, re-evaluation, diagnosis, and disposition for each patient in the Medi-tech system
- As part of the ER team in a Level 2 Trauma Center, effectively communicate with emergency physicians on the status of their patients
- Completed Chief Scribe training before the scribe program ended at Blake Hospital and transferred to Brandon Regional Hospital
- Awarded Scribe of the Year in 2017.
Processor
Clayton Holdings LLC
01.2011 - 01.2015
- Provided support for multiple mortgage Due Diligence and Underwriting projects by obtaining loan documentation including written and verbal verifications and reports
- Created Excel spreadsheets to organize and track loans
- Combined PDF files in Adobe Acrobat, created folders, indexed, extracted, moved, and uploaded documents
- Entered specific project data into Clayton’s proprietary loan and tracking systems
- Communicated with financial institutions regarding the delivery of loans and turnaround times, and effectively communicated with project leads and project transaction managers
- Averaged 40-70 loans per day in production.
Education
IATA Certification -
10.2022
Clinical Research Fastrack -
10.2020
HIPAA Certification -
09.2020
DaVita: Completed Patient Care Technician Central Catheter Training -
12.2019
Basic Life Support Provider -
09.2019
University of South Florida: Obtained Bachelor of Science in Public Health -
05.2017
Hillsborough Community College: Obtained AA Degree -
08.2014
Skills
- eTMF (Clinergize, Florence, RealTime, CLIX, RhoPortal, Sharepoint)
- Chair Side Snappy
- Medi-tech Electronic Health Record System
- Excel
- Word
- Windows
- Outlook
- Internet
- PowerPoint
- Adobe Acrobat (Proficient)
- Clayton E-clas Loan System
- Appian Tracking System
Websites
Timeline
Senior Regulatory Coordinator
CenExel ForCare Clinical Research
10.2022 - Current
Regulatory Coordinator
CenExel ForCare Clinical Research
07.2022 - 10.2022
Regulatory Coordinator
Stedman Clinical Trials
04.2021 - 07.2022
Certified Clinical Hemodialysis Technician/Vascular Access Manager
DaVita Dialysis Clinic
07.2019 - 04.2021
ER Scribe
ScribeAmerica
07.2016 - 07.2019
Processor
Clayton Holdings LLC
01.2011 - 01.2015