Andrew Wise

Data & Safety Monitoring Committee Program Director at University of Colorado Anschutz Medical Campus
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Contact Information
us****@****om
(386) 825-5501
Location
Denver, Colorado, United States, US
Skills

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Credentials

  • Certified Clinical Research Associate (CCRA®)
    Association of Clinical Research Professionals
    Oct, 2012
    - Oct, 2024
  • Certified Clinical Research Coordinator (CCRC)
    Association of Clinical Research Professionals
    Oct, 2016
    - Oct, 2024
  • Association of Clinical Research Professionals - Certified Professional (ACRP-CP®)
    Association of Clinical Research Professionals
    Apr, 2018
    - Oct, 2024

Experience

  • University of Colorado Anschutz Medical Campus
    • United States
    • Higher Education
    • 700 & Above Employee
    • Data & Safety Monitoring Committee Program Director
      • Sep 2016 - Present

      Drives institutional quality assurance program overseeing oncology trials across the University of Colorado system; interpreting policies, standards and regulations to ensure unit compliance with NCI requirements and applicable regulations. Serves as administrative representative of DSMC to internal and external audiences, providing QA metrics, guidance, counsel, and training to internal stakeholders at regular intervals. Reviews all Cancer Center protocols to ensure appropriate oversight is in place commensurate with the risk of the trial. Manages the day-to-day operations of DSMC auditing team that audits 50+ protocols annually and facilitates all aspects of committee activities and services. Authored multiple Cancer Center-level SOPs. Contributes as an item writer and quality control participant for professional certifications through Association of Clinical Research Professionals (ACRP).

    • DSMC Auditor
      • Apr 2014 - Sep 2016

      Ensure clinical trials are conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures, Good Clinical Practices & Code of Federal Regulations. Assure adherence to all research standards as set fort by the FDA, Office of Human Research Protections, University of Colorado Hospital, University of Colorado Denver & National Cancer Institute. Audits Cooperative Group clinical trial protocols as well as Investigator Initiated Protocols. Ensure written procedures are followed and evaluates quality systems, processes, procedures and protocols for safety and compliance.

  • Collaborative Neuroscience Research (CNS), a division of Apex Innovative Sciences
    • United States
    • Research Services
    • 1 - 100 Employee
    • Ph I-III Study Coordinator
      • Sep 2008 - Aug 2013

      Established a new inpatient Phase I department and implemented site systems, processes, documentation and communication plans for 20 bed facility. Manage team of 15+ employees conducting 2-5 projects simultaneously under tight timelines and protocol constraints. Responsible for training and oversight in a fast paced, high intensity environment for department with roughly $5 million dollars in revenue. Utilize and QA variety of data capture systems including Clinical Conductor, Medidata RAVE, InForm and others. Continually develop, implement and improve variety of tracking systems and metrics to increase efficiency, reduce redundancies and expedite query resolution. Consulted for new branch office and identified corrective actions to increase billable visits and streamline office workflow. Conduct in-person project status updates every 4-6 weeks depending on the contract.

  • Boling Clinical Trials
    • Assistant Director
      • Jan 2007 - Sep 2008

      Played critical role in company reorganization for increased productivity, reduction of study issues, and 30% company growth in studies and revenue. Assisted in oversight of clinical research company with 30–35 employees, and annual revenues of $2.5 million. Supervised 45–50 phase 1–4 IND trials and managed day to day operations including staff performance, auditing of records, and support of investigators, sponsors, study monitors and participants. Successfully hosted FDA audits. Created and conducted regular training and team building activities resulting in a stronger, more cohesive team.

  • University of Colorado Health Sciences Center
    • Research Services
    • 300 - 400 Employee
    • RA/Study Coordinator
      • Jun 2004 - Dec 2006

      Executed all aspects of multiple Phase 2-4 studies from start up through closeout for department with annual revenue of $3.8 million. Solicit local businesses through community outreach to participate in large scale wellness program. Led recruitment and information sessions with 10-20 patients and their families. Responsible for authoring consent forms and study related material for regulatory and sponsor approval. Assisted in the design and implementation of database system for data collection in multiple studies.

Education

  • Colorado State University
    Bachelor's degree, Political Science
    2000 - 2004

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