Joni Harris Email & Phone Number

Providence, Rhode Island, United States

Seattle

Charleston, South Carolina

Research relevant RFP/PA for potential funding opportunities; work directly with faculty and departmental leadership in proposal development; develop budgets and budget justifications in accordance with agency guidelines; determine and resolve potential fiscal issues such as cost sharing and possible request for waivers; coordinate all relevant documentation for the submission process including justifications, scope of work, biosketches, letters of support, and other supporting documentation; facilitate timely submission and renewal of VA MOUs, progress reports and Just In Time requests; prepare monthly PI reports for all Departmental Research faculty (approximately 100 faculty) to ensure compliance with university and sponsor guidelines and to reduce the risk of cost overruns; prepare all federal and private proposals for department and university approvals

Charleston, South Carolina

Developed quality assurance and continuous improvement initiatives; prepared for and conducted routine audits of studies as required by the sponsor and MUSC policy; identify, hire, train and manage study personnel; led new employee orientation and training on the Code of Federal Regulations, and Good Clinical Practices (GCP); served as team leader for the Thoracic, Head & Neck, Melanoma, Sarcoma and All Programs solid tumor program; managed study logistics; daily patient management including pharmacokinetics, pharmacogenomics and pharmacodynamics; contributed to multidisciplinary meetings to review patient safety and operational issues; served as a resource for ancillary services (laboratory, radiology, investigational pharmacy) to prevent/resolve any issues

Charleston, South Carolina

Screened all patients at the Hollings Cancer Center for possible inclusion into an active oncology clinical trial; informed potential patients on study specifics; coordinated all procedures and treatments in compliance with protocol requirements; timely and accurately submitted data to sponsor and institutional databases; attended and actively participated in Disease Specific Focus Group Meetings; presented pertinent research related data to investigators; maintained up to date protocol information, communication and education of study and clinic personnel; assisted in planning, implementing, and evaluation of program expansion and new projects, including the development of a statewide newsletter to educate community providers about the research portfolio; reviewed new protocols relative to operational feasibility and potential operational issues prior to scientific review committee meetings; assisted in preparation of research budgets

Charleston, South Carolina Area

Qualified to perform seven radiological tests on samples per client specifications, safely handled and disposed of radioactive and hazardous materials, adhered to Good Laboratory Practices, complied with federal regulations, completed batch records to be sent to clients; audited colleagues’ records to confirm compliance and accuracy

East Walpole, Ma

Manufactured reagents for use with ADVIA Centaur machines; tested reagents for quality control using patient blood samples; performed weekly and daily maintenance of ADVIA Centaurs; adhered to Good Manufacturing Practices and Good Laboratory Practices; generated detailed batch records; maintained inventory and ordered supplies when necessary; analyzed data reports; composed spreadsheets to summarize data; complied with domestic and international medical device regulations

Master Of Science (M.S.), Regulatory Affairs For Drugs, Biologics, And Medical Devices

Bachelor Of Science (B.S.), Biological Sciences

Activities and Societies: National Student Exchange