Brandon Hines

Senior Clinical Research Associate @Premier Research

Sacramento, CA, US

Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines • Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements • Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations • Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan. • Manages query resolution process with sites and Premier Research Data Management • Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates. • Assists project team with assessing project feasibility and recruitment, as applicable • Maintain communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts. • Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan • Acts as a resource/mentor for other CRAs and shares knowledge base and best practices. Perform observation and sign off visits to train junior CRAs Therapeutic Areas: Analgesia, Pediatric Metabolic, and Mental Health (Social Anxiety, Substance Use Disorder)

University of Southern California

MS, Regulatory Science

San Francisco State University

Certificate, Clinical Trials Design and Management

California Polytechnic State University-San Luis Obispo

BS, Biochemistry