Brandi (Stults) Halstead Email & Phone Number

Weatherford, Tx, Us

United States

• Review electronic medical records (EMRs), patient charts, and other data sources to identify and extract relevant information.• Enter data into databases or registries accurately and efficiently, adhering to specific guidelines and formats.• Verify and cross-check the data to ensure completeness, accuracy, and compliance with regulatory standards.• Generate reports based on abstracted data for use in clinical research, quality improvement, or regulatory compliance.• Ensure all data abstraction activities comply with federal, state, and institutional regulations, including HIPAA and other patient privacy laws.• Work with healthcare providers, researchers, or data management teams to clarify information and ensure data consistency.• Assist in identifying and implementing processes for improving data quality and workflow efficiency.

• Lead and orchestrate the clinical site feasibility process, supporting both Business Development through pre-study questionnaires and data collection for proposals, and Clinical Operations during engagement in a clinical trial. • Cultivate and nurture relationships with sites and vendors to bolster Catawba's clinical trials. • Collect Confidentiality Disclosure Agreements (CDAs) and maintain the highest level of confidentiality.• Collaborate with the Proposals Team to develop questionnaires and communications, offering insights and guidance on operational strategy for cost proposals. Provide expertise in the feasibility process to internal and external clients, offering strategic input to Business Development, Clinical Operations, and Sponsors. • Contribute to pre-study activities, including reviewing clinical protocols, study assumptions, client information, and study plans for both U.S. and global trials. • Conduct comprehensive research, analysis, and compilation of information on therapeutic areas outlined in the clinical protocol. Assess factors such as incidence, prevalence, standard of care, treatment trends, and competing trials to provide an overall assessment of study plan feasibility. • Interface with consultants, partners, and internal/external sources to gather and share critical feasibility information. • Design and administer site surveys/questionnaires, soliciting investigator feedback on projected enrollment, study feasibility, and site capabilities. • Supervise the site information collection process, analyzing compiled data for trends and site capabilities. • Contribute insights to proposals, aiding in the development of project assumptions, budgets, and timelines. • Engage in strategy meetings with both internal and external stakeholders. • Assist in the development and updating of Standard Operating Procedures (SOPs). • Establish and maintain a comprehensive Site and Vendor List, including relevant contact information.

Weatherford, Texas, United States

• Proposes research sites to be approached for new trials; provide site performance metrics to enable good decision-making by project teams• Assist with developing site enrollment projections.• Maintain and routinely update site performance metrics• Prepare and negotiate confidentiality agreements between research sites and Sarah Cannon within the parameters established by Sarah Cannon legal counsel and sponsor organizations.• Work with research sites to complete feasibility and site demographic information and establish sites’ interest in the study and ability to meet recruitment targets• Serves as a member of assigned project teams and perform start-up activities as needed by the project team for assigned trials• Communicates and escalates unresolved issues at the appropriate time and to the appropriate people.• Maintains database with accurate and current site profile information, key contacts, capabilities and historical site performance metrics, which are used to create accurate site assessments for study start up processes.• Establishes key relationships with research sites, internal stakeholders and other departments.• Ensures the appropriate stakeholders are informed of key site activities and issues are escalated to stakeholders appropriately.• Responsible for oversight of sites’ interactions across all global services studies for assigned sites; notifies project teams of any new site information that may affect their trials• Maintains strictest confidentiality• Adheres to professional standards and SOPs established for clinical research

Fort Worth, Texas, United States

-Screen and Consent patients for potential study enrollment-Coordinating patient follow up visits and timely data submission-Assist with collection, processing and shipping of lab specimens-Upload imaging to central imaging vendors-Order and maintain lab supplies-Maintain research records in a confidential manner according to practice policies, HIPPA guidelines and other applicable regulations-Actively prepares for and participates in monitoring visits-Work with a variety of EDC, IWRS, Lab and Imaging PortalsTranscribe study data into case report forms -Direct study start-up process fro the pre-site selection visits through site activation-Maintain all regulatory documents including: Financial Disclosure Forms, 1572's, Delegation logs, DOA profiles, IND safety reports, and IRB submissions-Ensure ML's, GCP training, Iata training, and CV's are kept up to date-Create Protocol Specific training and ensure site staff completes training in a timely manner-Create treatment sheets to assist study coordinators with patient visits