Patricia Cobb Email and Phone Number

Mentor and train junior research coordinators. Protocol development (from idea to protocol creation) and execution. Feasibility analysis, contract and budget negotiations, and study completion. Collaboration across divisions for ophthalmology exams for both NIH and pharmaceutical studies. Creation of Epic functionalities to enhance research output.

- Project Manager for a single patient Phase 1 study. Study specific responsibilities include:o Overall coordination for a combination product (IND/IDE) study including timeline, budgets, regulatory requirements, patient communications, investigational drug and investigational device processes.o FDA IND preparation, submission and correspondence. o Evaluation and determination of FDA IDE non-significant risk (NSR) status.o Preparation and submission of initial IRB approval… Show more - Project Manager for a single patient Phase 1 study. Study specific responsibilities include:o Overall coordination for a combination product (IND/IDE) study including timeline, budgets, regulatory requirements, patient communications, investigational drug and investigational device processes.o FDA IND preparation, submission and correspondence. o Evaluation and determination of FDA IDE non-significant risk (NSR) status.o Preparation and submission of initial IRB approval, amendments and continuing reviews at CCHMC. Establish reliance documentation with two other independent sites.o SOP, MOP, CRF creation and maintenance.o All data collection and source document maintenance. o Training of study staffo Conduct the informed consent process.o Participate and prepare for monitoring visits. o Adverse event reporting to the appropriate agency.Other responsibilities:- Conduct daily research activities such as the informed consent process, data collection and analysis.- Document and report protocol deviations, violations and adverse events to the appropriate agency in a timely manner. - Create and maintain regulatory binders for all studies.- Communicate with two local IRBs and maintain approvals for studies. Establish reliance at another site. Responsibilities inclusive of initial study application, continuing reviews, amendments and study close outs.- Create and regularly update SOPs for all studies.- Serve as a liaison between contracts and budgets externally (study sponsors) and internally (CCHMC) for study start up.- Assess feasibility of external division protocols in the ophthalmology clinic. Educate ophthalmology staff on ophthalmic study procedures to ensure study visits are compliant with protocol.- Member of the Ophthalmology Outcomes Project. Contribute ideas to analyze and apply interventions to improve outcomes. Specific outcome measures available by request. Report results on a division and hospital level. Show less

Specific responsibilities included:- Developed and maintained standard operating procedures for a College of American Pathologists (CAP)/Clinical Lab Improvement Amendments (CLIA) certified laboratory.- Completed laboratory tests such as processing of blood, stool and saliva in compliance with CAP/CLIA guidelines.

Taught a non-majors Introductory Biology lecture course. Responsible for syllabus and course development, lecture creation, creating/grading all exams/homeworks.

Taught introductory biology as well as microbiology labs while completing my master's degree.