Danielle Buchanan Email & Phone Number

Nashville, Tn, Us

Nashville, Tennessee, United States

Subject Matter Expert in clinical trials, making recommendations for continuous improvement, providing training as appropriate/required and mentoring junior clinical research coordinators

Conducts investigational drug trials in patients with Mild Cognitive Impairment and Huntington’s disease. Prepares and processes new IRB research proposals, amendments, continuing review application and adverse event reports according to institutional and departmental policies and procedures and federal regulations. Prepares and maintains documents required for regulatory authorities and the sponsor. Assists with patient recruitment and screening according to protocol-specified inclusion and exclusion criteria. Conducts specific cognitive and motor assessments with patient per protocol. Records data from source documentation and participation interaction onto case report forms and attends to query resolutions in a timely manner. Collects, processes and ships patient specimens according to protocol. Familiar with safety reporting requirements of the study protocols and coordinates activities as well as gathers information from various sources to achieve study outcomes. Manages a team of 6 clinical research coordinators. Networks with other research departments and colleagues to share best practices. Supports process improvement in clinical/translational research management to speed up study activation, implementation, conduct, close out, and reporting. Credentialed Huntington’s Disease Study Group Coordinator. Certified to give the following cognitive assessments: Columbia-Suicide Severity Rating Scale, Hospital Anxiety and Depression Scale, Montreal Cognitive Assessment, Problem Behavioral Assessment.

Nashville, Tennessee

Conducts investigational drug trials in patients with Mild Cognitive Impairment and Huntington’s disease. Prepares and processes new IRB research proposals, amendments, continuing review application and adverse event reports according to institutional and departmental policies and procedures and federal regulations. Prepares and maintains documents required for regulatory authorities and the sponsor. Assists with patient recruitment and screening according to protocol-specified inclusion and exclusion criteria. Conducts specific cognitive and motor assessments with patients per protocol. Records data from source documentation and participation interaction onto case report forms and attends to query resolutions in a timely manner. Collects, processes and ships patient specimens according to protocol. Familiar with safety reporting requirements of the study protocols and coordinates activities as well as gathers information from various sources to achieve study outcomes. Manages a team of 6 clinical research coordinators. Credentialed Huntington’s Disease Study Group coordinator. Certified to give the following cognitive assessments: Columbia-Suicide Severity Rating Scale, Hospital Anxiety and Depression Scale, Problem Behavioral Assessment.Worked on the following trials: Vaccinex SIGNAL, Cerecor Clin-301-101, CHDI Enroll HD, ROCHE/GENENTECH Generation HD1

Maintains data pertaining to multiple myeloma phase I-III clinical trials, completes source documents/case report forms, and performs data entry. Assists with patient recruitment and screening according to protocol-specified inclusion and exclusion criteria. Reviews medical records, performs interviews and quality of life questionnaires. Collects and processes study specimens according to protocol. Coordinates services, schedules procedures, creates and maintains case reports, and monitors charges. Communicates all AE’s, SAE’s and protocol deviations to the regulatory team. Worked on the following trials: Celgene A Study to Determine Dose and Tolerability of CC-220 Monotherapy, in Combination With Dexamethasone, and in Combination With Dexamethasone and Daratumumab or Bortezomib in Subjects With Relapsed and Refractory Multiple Myeloma, Janssen MMY1001, Jansen MMY3003, Bristol Myers Squibb CA204004, AMGEN CANDOR Study of Carfilzomib and Daratumumab for Relapsed Myeloma

Decatur, Ga

Leads patient recruitment and enrollment, documentation/reporting, data quality control, and study/lab compliance for outsourced clinical trial projects supporting world-class pharmaceutical client R&D.Trials included type 2 diabetes, migraines and osteoarthritis.

Greater Atlanta Area

Physicians' Care Clinic is a "free" multi-discipline clinic, in DeKalb county, for un-insured patients staffed by volunteer physicians. Supports clinical staff addressing the needs of underserved patient base. Provides billing, scheduling, and documentation services.

Tampa/St. Petersburg, Florida Area

After 3 years of participation with this student activity board, elected into president-level role to oversee the planning and direction of 50+ annual events. Chaired board of 9 event directors, managed $100K budget, led marketing efforts, and secured vendor contracts.

Tampa/St. Petersburg, Florida Area

Assisted in research of geneticist, Dr. Maxine Sutcliffe. Developed/presented list of pediatric genes for genetic disease investigation.

Tampa/St. Petersburg, Florida Area

Participated in independent research on environmental toxins and Parkinson's disease. Prepped specimens of nematode round worms (C. elegans) used in measurement of Parkinson’s disease phenotypes. Managed inventory, set-up/cleaning, and compliance with OSHA regulations within chemistry/biology labs supporting undergraduate curricula as well as undergraduate/faculty research.

Tampa/St. Petersburg, Florida Area

Responsible for a residence house co-ed community of 30+ students, primarily Freshmen, including campus policy enforcement. Planned community building events, oversaw problem negotiation and mediation, available 24/7 as role model.

Nashville, Tn

Selected to lead biomedical informatics research project funded through National Institute of Health. Documented 20-year history of groundbreaking efforts in electronic medical records which support care of 1.6M+ patients and 35,000+ surgeries annually.

Bachelor Of Science (B.S.), Biology, General

Activities and Societies: Director of Palmetto Productions President of Eckerd College's chapter of Her Campus Vice President.

Post Baccalaureate, Pre-Medicine/Pre-Medical Studies

Highschool Diploma