Allison Mathews Email & Phone Number

Chapel Hill, Nc, Us

- Prepare VA-specific protocol, informed consent form, HIPAA authorization, DUA, and other related documents for initial review by the IRB- Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, adverse event reports, and any other IRB-required submissions- Assist new hires in completing and submitting all required paperwork and trainings- Track training status and Scopes of Practice of existing staff, assisting with updates as needed- Maintain electronic and paper documentation of regulatory paperwork and training- Coordinate internal audits of enrollment documents- Coordinate meetings with VA and external auditors and monitors to review paper and electronic regulatory files, study binders, enrollment documents, and study documents- Adhere to safety and compliance regulations

- Develop clear and concise technical documentation, including user manuals, guides, and reports, to effectively communicate complex technical concepts to diverse audiences.- Collaborate to gather and verify technical information for accurate documentation.- Organize and structure content logically, ensuring coherence and usability, while adhering to established style guides and documentation standards.- Conduct thorough research and analysis to understand product functionality and features, translating technical specifications into easily understandable language for end users.- Review and edit existing documentation for accuracy, completeness, and consistency, implementing revisions as necessary to improve clarity and readability.

Knoxville, Tennessee, United States

- Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm the implementation of appropriate methods, practices, and procedures for all research activities- Develops accurate source materials and ensures compliance from site staff- Provides accurate and timely data collection, documentation, entry, and reporting in databases- Ensures appropriate credentialing and training of the entire site staff- Supports the regulatory staff in the maintenance of regulatory documents in accordance with site SOP and applicable sponsor regulations- Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol- Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants- Ensures compliance with research protocols by providing ongoing quality control audits, including maintaining ongoing investigational drug accountability

Knoxville, Tennessee, United States

- Greet patients and hand out forms pertaining to scheduled surgery - Maintain medical charts; vital signs; and patient information- Ensure documents are filed in an organized and timely manner- Monitor Cerner Application for patient locations and relevant information- Collaborate with medical and non-medical staff- Undertake tasks delegated by supervisors and team members

Knoxville, Tennessee, United States

- Took care of approximately 18 elderly, disabled and hospice patients daily- Provided patients/residents with compassion and companionship- Monitored and reported vital signs in patient electronic health record- Aided residents with personal hygiene- Assisted residents with activities of daily living- Changed bed linens and performed light housekeeping- Cleaned and sanitized rooms- Aided in lifting residents when necessary- Coordinated activities for residents- Assisted with wound care- Performed post-mortem care, if needed

- Assist UT Athletic Department employees and students in the completion of routine COVID-19 testing.- Interpret and report results of COVID-19 tests to the responsible tracing departments.- Update student information in an electronic health record system- Ensure that all new and pending testing kits are stored properly.- Maintain documentation needed for continued COVID-19 testing.- Perform duties in compliance with HIPAA and IRB/GCP guidelines.- Assist with the investigation of COVID-19 positive cases and potential exposures.

Clinical And Regulatory Sciences Graduate Certificate, Regulatory Affairs

Cedars-Sinai Cancer’s Graduate Certificate in Clinical and Regulatory Sciences is a component of the graduate education programs intended.

Bachelor Of Science - Bs, Biochemistry And Molecular Biology