Brandon Hines

About Brandon Hines

Clinical research professional having five years of monitoring experience in multiple therapeutic areas from study start up to close-out. A varied background in biotech start-ups, CROs, and the FDA helps to ensure that clinical trials are conducted in an ethical, compassionate and compliant manner. Therapeutic Areas- Rare Metabolic Diseases/Lysosomal Storage Disorders (Ph Obstetrics/Gynecology (Ph Analgesia (Ph II)- Dermatology (Ph Rheumatology (Ph Skills- Monitoring - Vendor Management - CRO Oversight - TMF/eTMF - GCP Compliance - Inspection Readiness - Drugs/Biologics Regulations (21 CFR, ICH E6, EU Directives) Strengths- Strategic - Futuristic - Deliberate - Analytical

Experience

1. Senior Clinical Research Associate

   Premier Research

   Mar 2022 — Present · 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)

Education

• University of Southern California

  MS, Regulatory Science

  2014 — 2017

• San Francisco State University

  Certificate, Clinical Trials Design and Management

  2016 — 2016

• California Polytechnic State University-San Luis Obispo

  BS, Biochemistry

  2010 — 2014