Robert Haugen

Experience

• 

  Quintiles

  Jan 2008 - Aug 2011

  • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.• Provide assistance in training and mentoring less experienced clinical staff.Function as lead CRA in multi protocol Parkinsons Project. Show less • Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.• Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.• Collaborate with CTL on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.• Assist in training and orienting new staff. Acted as a mentor for less experienced CTAs.• Managed Trial Master Files for Phase i Influenza and 4 Phase III Allergy studies Show less

  • Sr. Clinical Research Associate / Clinical Research Associate

    Dec 2008 - Aug 2011

  • Sr. Clinical Trials Assistant

    Jan 2008 - Dec 2008
• 

  PRA Health Sciences

  Aug 2011 - Jan 2016

  Monitors the progress of clinical studies at investigative sites, and ensures that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.•Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines•Performs investigative site file reconciliation; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements Show less

  • Clinical Team Manager III

    Jul 2012 - Jan 2016

  • Clinical Research Associate III

    Aug 2011 - Jul 2012
• 

  PRA Health Sciences

  Apr 2016 - Aug 2021

  • Assoc Director, BRM Data and Analytics

    Nov 2020 - Aug 2021

  • Manager Business Intelligence

    Apr 2016 - Nov 2020
• 

  ICON plc

  Aug 2021 - now

  • Directior Project Delivery

    Sept 2022 - now

  • Director Data and Applied Analytics

    Aug 2021 - Sept 2022