Christine Horne Email & Phone Number

Charleston, Sc, United States

Lead development and implementation of robust procedures and maintain strict adherence to clinical research protocols and administrative requirements to foster culture of compliance and efficiency. Analyze feasibility and optimize management of research protocols from study start-up through study close-out for optimal outcomes in close collaboration with research team, study sponsors, CROs, vendors, and other clinical research professionals. Steer end-to-end employee management activities, including applicant interviewing, performance evaluation, professional development, and job description preparation.

Charleston, South Carolina

Headed collaborative efforts with clinical operations and quality assurance teams to support adherence to FDA Regulations, institutional guidelines, and International Council for Harmonisation (ICH) Good Clinical Practice (GCP). Orchestrated overall development, collection, tracking, and dissemination of regulatory documents from diverse study sites to execute reviews for alignment with FDA Regulations, Sponsor directives, and institutional Standard Operating Procedures (SOPs), while verifying compliance and document integrity throughout trials.

Charleston, South Carolina Area

Steered end-to-end direction and program management of multi-site clinical trial. Delivered oversight to rigorous quality assurance and data monitoring reviews, culminating in creation of comprehensive, precise, and regulation-adherent progress reports for pivotal study sessions, including annual Data Safety and Monitoring Board meetings. Formulated and refined SOPs through cross-study site training and communication, as well as innovated electronic case report forms database. Managed personnel matters, encompassing applicant evaluation and selection, performance assessment, professional advancement, and formulation of job descriptions to select top-performing player.

Charleston, South Carolina Area

Incorporated unwavering regulatory compliance and elevated quality assurance standards across research sites within esteemed Southern Consortium Node of NIDA Clinical Trials Network (CTN), dynamic multi-project, multi-site NIH-funded grant. Performed onsite monitoring visits to examine study documentation, administer investigational product (IP) accountability, and guarantee alignment with FDA Regulations, institutional mandates, and International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. Crafted comprehensive progress reports for effectively communicating study advancements to both national and local investigators.