Clinical Trials Process Improvement Specialist
Resume:
Bridget Dancs
***** ******* ***** **., ***********, WA 98826
************@*****.***
SUMMARY
Secure a position in a Clinical Trials environment that allows me to use my experience in Process Improvement for Home Healthcare for Clinical Trials and as a Clinical Trial Monitor and my dedication to quality to ensure an environment of excellence.
EMPLOYMENT HISTORY
Lake Wenatchee Fire & Rescue December 2022 – Present Community Outreach Care Coordinator (Part-time)
• Responsibilities as Care Coordinator include the following: o Establish and maintain home visit (vitals checks) schedules with clients o Initiate emergency calls if needed during home visits o Provide referrals to additional services as required o Report to APS and CPS as needed
o Document home visits and interactions as specified by funding agency Marken (Remote) September 2020 – February 2024
Senior Process Coordinator April 2022 – February 2024
• Responsibilities as a Senior Process Coordinator include the following: o Support the Global Patient Centric Services (GPCS) team with process improvement based on FDA and GCP requirements, audit findings, and corrective and preventative actions (CAPA) o Collaborate with the training team on the roll out of new materials o Form cross functional teams to implement process improvement initiatives Senior Country Coordinator July 2021 – March 2022
• Responsibilities as a Senior Country Coordinator include the following: o Coordinate study activities for the Country Coordinator team o Provide regular study updates to the Project Manager o Review Key Performance Indicators and action any that are below expectations o Complete Country Coordinator activities as needed Country Coordinator September 2020 – July 2021
• Responsibilities as a Country Coordinator include the following: o Coordinate Home Healthcare (HHC) visits for clinical trials for Investigator Sites o Train Home Healthcare Providers (HHCP) on study specific materials and GCP and ensure qualification and approval documentation is completed o Ensure that all source documentation is completed and provided to the Investigator Site in a timely manner
o Ensure that HHCP documents are maintained and provided to sites for their TMF o Coordinate logistics for HHC visits
Nor-Consult, LLC February 2013 – September 2020
Clinical Research Associate
• Responsibilities as a Clinical Research Associate include the following: o Ensuring adherence to FDA regulations and GCP at multiple clinical sites o Utilizing logic checks to remotely monitor data in EDC systems o Conducting onsite monitoring of clinical sites (varying degrees of source data verification depending on the protocol)
o Tracking subject follow up rates and working with clinical sites to improve follow up rates o Working with clinical data programmers and sites to ensure proper AE/SAE reporting o Ensuring clinical sites are current with IRB/REB approvals o Working with clinical sites to ensure maintenance of the TMF o Providing clinical sites with education for any changes to study protocols or study personnel o Providing clinical sites with re-education if any issues arise o Maintain regular communication with the sponsor team to provide study updates o Creation of status reports for sponsors
o Aide in creation/review process for study documents (e.g., source worksheets, study protocol, training materials, Data Management Plan)
o Assist in creation/validation of EDC systems
• Specific Accomplishments as Lead Monitor
o Assisted in PMA submission
o Participated in month long FDA audit at our CRO
StratusG LLC March 2013 – October 2013
Project Management Consultant
• Responsibilities as a Project Manager for an IT department include the following: o Development and documentation of routine processes o Managing timelines for multiple projects being undertaken by IT department o Developing resource tracking system for members of the department o Managing IT specific portion of multiple office renovations throughout the country o Assisting in recruitment, hiring, and training of full time Project Manager Nor-Consult, LLC June 2011 – January 2013
Clinical Research Assistant
• Responsibilities as a Clinical Research Assistant include the following: o Prepare site and monitor for monitoring visits
o Assisting monitors in creation of all necessary documents o Scheduling meeting and taking minutes for all study meetings o Completing filing of all study documents relating to study sites o While employed as Clinical Research Assistant, training for Clinical Research Associate was completed. This involved in office training with the monitor team and on-site visits with the monitoring team.
DaVita September 2009 – May 2011
Hemodialysis Technician
• Responsibilities as a Hemodialysis Technician include the following: o Initiating, monitoring and discontinuing hemodialysis treatments o Ensure prescribed treatment provided to patients o Monitoring up to 12 patients at a time to ensure stable vitals o Monitoring water treatment systems
o Mixing solutions used for hemodialysis treatments VOLUNTEER EXPERIENCE
Lake Wenatchee Fire & Rescue September 2022 – Current Firefighter/EMT
• Duties of a volunteer firefighter/EMT include the following: o Complete regular training within the department including trainings in the National Incident Management System (NIMS)
o Respond to emergency calls dispatched (e.g.,structure fires, motor vehicle accidents, snowmobile accidents, swiftwater rescue incidents, medical calls) EDUCATION
Camden Coalition
• Community Health Worker Certificate (2025)
National Fire Academy
• March 2025 Analytical Tools for Decision Making: 6 day in person course focused on analytical tools for Fire Service/EMS
Beyond The Streets
• 2 day leadership course specifically focused on EMS supervision
• Completed October 2024
West Zone Fire Academy
• Structural firefighter academy
• September 2024 – November 2024
Emergency Medical Technician Course
• Completed May 2023
• WA EMT Credential # ES61504952
Life Science Training Institute
• Monitoring Medical Devices ISO 14155 (2018)
SoCRA: Los Angeles, CA
• Clinical Research Monitoring and GCP Workshop (2013) DaVita DSS Leadership Course
• Six month leadership course focusing on leadership in a healthcare setting. Designed for potential growth into a facility administrator role. (2010)
University of Washington: Seattle, WA
• Clinical Trials Certificate (2011)
• BA Chemistry (2004)
HONORS AND AWARDS
Lake Wenatchee Fire & Rescue
2025 Firefighter of the Year
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