Hannah Kelly
Clinical Research Coordinator
- Role
- Clinical Research Coordinator Ii at Houston Mind & Brain
- Location
- Houston, TX, US
- LinkedIn followers
- 500 followers
About Hannah Kelly
Hannah Kelly\'s experience coordinating neurological and psychiatric research studies has…
Experience
Clinical Research Coordinator Ii
Jan 2023 — Present · Houston, TX, US
Regulatory compliance for a specified portfolio of clinical trials. This support includes, but is not limited to, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees and ensuring successful navigation of approval processes for clinical research- Provides protocol feedback, prepares protocol documents and required regulatory forms in order to obtain company and regulatory agency approval- Negotiates budgets and contracts for industry sponsored trials and investigator initiated trials- Train junior staff and serves as a resource to staff for general regulatory guidance-Acts as a liaison between review committees, regulatory agencies and the investigators to ensure that protocols obtain applicable approvals, that protocol amendments are submitted appropriately and that annual renewals are obtained-Works closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date-Facilitates communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting-Maintains electronic and paper study files in accordance with local SOPs, sponsor and general industry standards ensuring documentation is complete, up to date, and audit ready-Practices a high level of integrity and honesty in maintaining confidentiality-Plans and pursues activities to promote self development related to clinical research and regulatory issues-Administers TMS (transcranial magnetic stimulation) and Spravato to patients, and appropriately documents treatments in the medical record-Assists with the development and revision of SOPs and data tracking processes for clinical outcomes related to TMS and Spravato-Administers neurocognitive assessments and assists with the development and revision of SOPs for neurocognitive assessments.
Education
Sam Houston State University
Bachelor of Science - BS
2018 — 2021
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