Kelly Potts Email and Phone Number

Understanding and expertise of projects assigned, including knowledgeable of study protocols, site monitoring plan, study manuals, and regulatory requirements. Aids in collecting, reviewing, and maintaining regulatory documents. Reviews and contributes to project documents and modifications of study materials. Participates and effectively communicates with Sponsors, Sites, and Colleagues.

Understanding and expertise of projects assigned, including knowledgeable of study protocols, site monitoring plan, study manuals, and regulatory requirements. Aids in collecting, reviewing, and maintaining regulatory documents. Reviews and contributes to project documents and modifications of study materials. Participates and effectively communicates with Sponsors, Sites, and Colleagues.

As a Breast Cancer Clinical Research Coordinator with Inova Schar Cancer Institute:Routinely communicates with patients and families, coordinates outpatient care, and works with physicians, clinical pharmacists, infusion and research teams to deliver highest level care for patients with advanced malignancies. Effectively executes clinical elements of research protocol conduct: Adheres to ICH- GCP, FDA, and Inova Health System guidelines when implementing research trials to ensure highest quality research within Inova Health System. Effectively executes non-clinical elements of research protocol conduct, oversees accuracy of data and record-keeping, and coordinates with colleagues on regulatory and financial aspects of clinical trial implementation from protocol feasibility through to study termination. Collaborates effectively with program members and others outside the program to meet research study, departmental, and institutional objectives. Demonstrates respect and understanding of other clinical disciplines and departments.

Clinical Research ProfessionalImplement research trials while adhering to ICH- GCP and Inova Health System guidelines to ensure highest quality research and Human Subject protection from site selection to study closure. While also performing administrative functions to include data collection/management in order to support the accomplishment of the research department function and research project goals. Effectively communicates and works in collaboration with the research team in order to meet research study and department objectives. Learned and demonstrated understanding of other clinical disciplines and departments functions.o Extensive use of multiple electronic data capture systems o Consenting of patients for clinical trialso Screens patient records for identification of prospective candidateso Conducts patient visits and documents interactions in electronic medical recordso Adheres to the research protocol, institutional policies, and state and federal regulationso Entry of initial/follow-up patient datao Resolves data queries in a timely mannero Takes drawn samples, processes, and ships laboratory samples for clinical trialso Participates in site initiation visits

o Opening and closing the store and manager responsibilities when Store Manager is not presento Successfully resolved customer concerns using strong communication and problem-solving skillso Completion and handling of sales transactionso Customer service including answering customer inquires and solving customer issues.o Receiving new merchandise into the storeo Knowledgeable on merchandise and company history

Intern with the Schar Cancer Instituteo Shadow personnel on both clinical and regulatory sides of clinical trialso Read protocols for working knowledge of trials when shadowingo Furthered oncology knowledge o Participated in site initiation visitso Participated in using Redcapo Data entry

o Furthered clinical research skills through ACRP e-learning courseso Data entry into excel sheetso Aided in initial development of Mentor/Mentee programo Involvement in membership, training, and certification departmentso Edited and updated Governance Documents for upcoming yearo Significant use of Microsoft Office Suite