Taniesha Stewart
Miami,United States
Summary
I am a meticulous and detail-oriented individual with a fervent dedication to precision, thriving particularly in independent work settings. I possess a strong willingness to learn and readily adapt to new processes. With a Bachelor's degree in Health Information Systems and certification as an Electronic Health Records Specialist, I bring over 10 years of experience in the healthcare sector. Additionally, I possess proficient data analyst skills and extensive expertise in clinical data entry
Overview
6
6
years of professional experience
1
1
Certification
Work History
Medical Assistant
University of Miami Sylvester Cancer Center
Hollywood, FL
08.2023 - Current
- Maintained accurate medical records through filing, charting, transcription and data entry into electronic health record system.
- Adhered to HIPAA regulations regarding safeguarding confidential patient information at all times.
- Incorporated outside records into charts and EHR.
- Completed and submitted clinical documentation in accordance with agency guidelines.
- Uphold data integrity and confidentiality at all times. Maintain a high level of attention to detail and accuracy.
- Participate in training programs to enhance data entry skills.
- Assisted back office patient processes to reduce office wait times.
- Participated in team meetings to improve workflows and contribute to improving patient population outcomes.
Regulatory Maintenance
Actalent (Wilmot Cancer Institute)
Remote
05.2022 - 12.2022
- Prepared documents for submission to relevant authorities as needed.
- Communicated regularly with external stakeholders regarding status updates on submissions.
- Compiled product registration dossiers and ensured compliance with applicable regulations.
- Precisely input data into our systems from various sources. Examine and verify data for inconsistencies or errors
- Maintain data integrity and confidentiality consistently. Prioritize and organize data entry tasks to meet deadlines efficiently. Perform thorough quality checks on finished tasks.
- Collaborate with team members to ensure data accuracy and consistency. Provide support to other departments with data-related tasks.
- Maintained up-to-date records of product registrations, renewals, and notifications.
Regulatory Coordinator
Segal Trials Institute
Miami, FL
10.2021 - 05.2022
- Reviewed marketing materials to ensure accuracy of claims and compliance with labeling requirements.
- Maintained up-to-date records of product registrations, renewals, and notifications. Generate necessary reports and summaries.
- Coordinated activities between regulatory departments, manufacturing sites, and external customers.
- Provided support on regulatory issues related to product development, quality assurance, and safety standards.
- Organize and prioritize data entry tasks to meet deadlines. Address data entry issues as they arise.
- Ensured timely submission of documents required by health authorities for registration applications.
- Adhere to company policies and procedures for data management.
Clinical Research Associate
Xera Med Research
Miami, FL
01.2021 - 10.2021
- Performed clinical research activities including protocol development, subject recruitment and data collection.
- Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
- Conducted site initiation visits and monitored ongoing studies at investigator sites.
- Accurately input data into our systems from diverse sources. Thoroughly review and validate data for any inconsistencies or errors. Maintain utmost data integrity and confidentiality throughout the process
- Provided support in writing informed consent forms, patient diaries, study manuals.
- Prepared reports summarizing study progress and results for senior management review.
- Ensured timely completion of all deliverables by tracking project timelines and milestones.
- Drafted agendas, minutes and other meeting materials for Investigator Meetings or Advisory Boards.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Participated in educational training, activities and professional development programs.
- Attended investigator meetings to provide framework for successful research studies by establishing responsibilities.
Regulatory Assistant
Terumo Aortic
Sunrise, FL
05.2018 - 05.2020
- Assisted in the preparation of regulatory documents for submission to government agencies.
- Reviewed and edited regulatory documents for accuracy and completeness.
- Provided training to staff members on regulatory guidelines and procedures.
- Created reports summarizing data related to regulatory issues.
- Compiled information from various sources for use in regulatory filings. Conduct quality checks on completed work
- Monitored changes in regulations to keep abreast of current trends.
- Identified potential risks associated with non-compliance of regulations. Maintain a high level of attention to detail and accuracy.
Education
Bachelor of Science - Health Information System
University of Phoenix
Miramar, FL06-2015
Skills
- Strong attention to detail and organizational skills
- Ability to work independently and remotely
- HIPAA Compliance
- Medical Billing
- Data Entry
- Complex Problem-Solving
- Willingness to learn and adapt to new processes
- Proficient with EPIC, REDCap, SQL, MS Excel, Word, PowerPoint,
Certification
- Certified Electronic Health Records Specialist
References
References available upon request.
Timeline
Medical Assistant
University of Miami Sylvester Cancer Center
08.2023 - Current
Regulatory Maintenance
Actalent (Wilmot Cancer Institute)
05.2022 - 12.2022
Regulatory Coordinator
Segal Trials Institute
10.2021 - 05.2022
Clinical Research Associate
Xera Med Research
01.2021 - 10.2021
Regulatory Assistant
Terumo Aortic
05.2018 - 05.2020
Bachelor of Science - Health Information System
University of Phoenix
- Certified Electronic Health Records Specialist
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