Molly Kaiser (Fahrenkrog)

Molly kaiser (fahrenkrog)

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location of Molly Kaiser (Fahrenkrog)Eau Claire-Menomonie Area
Phone number of Molly Kaiser (Fahrenkrog)+91 xxxx xxxxx
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  • Timeline

    Oct 2011 - Jun 2015

    Lead Project Coordinator

    University of Wisconsin-La Crosse
    Jun 2013 - Sept 2013

    Summer Medical Research Fellow

    Gundersen Health System
    Dec 2014 - Jun 2015

    Clinical Research Coordinator Intern

    Mayo Clinic
    Current Company
    Aug 2015 - now

    Director

    PPD
  • About me

    Director at PPD, part of Thermo Fisher Scientific

  • Education

    • University of wisconsin-la crosse

      -
      Bachelor of science (bs) biological and biomedical sciences, writing emphasis
  • Experience

    • University of wisconsin-la crosse

      Oct 2011 - Jun 2015
      Lead project coordinator

      Acted as the lead coordinator for a hematology study investigating Amegakaryocytic Thrombocytopenia• Responsible for project design, setup and running lab procedures• Conducting training and supervision of new lab members, while ensuring ethical lab practice*Manuscript published

    • Gundersen health system

      Jun 2013 - Sept 2013
      Summer medical research fellow

      Conducted a fellowship study investigating Testicular Cancer and adhesion molecules• Developed, coordinated, and implemented research design, maintained patient confidentiality, summarized and theorized experimental data• Data entry of patient records pertinent to the study• Performed tissue sectioning with a microtome, staining using immunohistochemistry, and evaluation with a scanning electron microscope

    • Mayo clinic

      Dec 2014 - Jun 2015
      Clinical research coordinator intern

      Worked as an on-site monitor to carry out daily tasks of the study, complete patient evaluations, and work within applicable systems• Engaged in patient monitoring in a clinical setting, while maintaining the highest level of patient confidentiality• Independently completed patient data collection and conducted patient questionnaires• Executed full consent process• Played a vital role in the development of the study protocol and procedures, within GCP/ICH guidelines*Manuscript in submission Show less

    • Ppd

      Aug 2015 - now

      -Managed staff, provided coaching, mentorship and work direction -Conducted regular performance appraisals and career discussions with staff, while facilitating employee career development-Interviewed, recruited and selected staff -Supported allocation activities per the local resourcing process-Delivered training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact clinical operations; also contributed to development of training programs-Escalated quality issues, requested QA audits as appropriate, and facilitated client and internal quality assurance audits as required -Managed and reviewed systems to evaluate employee and project metrics, KPIs and general project status-Evaluated work of staff, including conducting sign-off and annual certification to thoroughly evaluate the employee monitoring skills and project conduction when applicable-Participated in process improvement/development initiatives-Provided input into bids and contributed to the procurement of new business-Managed 20-30 CRAs at a time Show less Oncology Logistics Coordinator:-Manage samples and site logistics for biotech Adoptive Cell Therapy and immunotherapy studies -Ensure regular and efficient communication with the study sites and sponsor RSM II tasks are the same as RSM (Level I) description, with the addition of the tasks below: -Act as a Subject Matter Expert for several vendor systems and internal processes-Lead and train new RSMs within my program and the organization -Assist with delegation and completion of Clinical Trial Manager’s (CTM) tasks Show less Currently working as a site monitor to perform remote monitoring visits and all applicable documentation/procedures*Experienced in Adaptive and Intelligent Monitoring (AIM) strategy and Risk Based Monitoring (RBM) • Work daily with eCRF’s to ensure accuracy and communicate with the research sites and sponsor• Open and close queries to verify data entered within the eCRF system• Communicate regularly with the site and sponsor to address any issues and relay pertinent study information• Ensure smooth transfer of imaging and study drug to and from vendors/site•Skilled with vendor management and have diverse experience with many vendor systems • Train study sites on procedures and documents• Perform remote site management activities on assigned projects in accordance with FDA and/or local regulations and guidelines, ICH GCPs and PPD procedural documents.• Review study data from various sources remotely. • Contact study sites to collect study documentation, resolve issues and request outstanding information.•Currently assigned to several Phase III Oncology studies *PPD Peak Performance Team Award Recipient: Quarterly award given to a select few clinical teams at PPD who exemplified achievement of excellent results through extraordinary efforts, high standards, and cohesive teamwork*2017 Exceptional Performance Reward: CEO awarded to individuals who showed tremendous performance and contribution in 2017 Show less Worked to assist all project teams with all applicable study documents and ensured complete data compliance within systems*Sponsor facing role • Was responsible for meticulous checking, filing, and transfer of regulatory documents to eTMF• Accountable for daily tracking and maintenance of CTMS in both PPD and sponsor CTMS systems• Maintained daily contact with sponsors and clinical sites• Played a vital role in the transition and continuation of study timelines• Have experience with Phase I & II oncology and asthma studies, at all stages of the clinical trial process (Feasibility, Startup, Interim, Close-out, etc.)• Completed project related work in both internal and sponsor systems o Lead multiple trainings to train internal project managers and directors on the complex sponsor systems Show less

      • Director

        Feb 2025 - now
      • Business Optimization Lead

        Jul 2023 - Feb 2025
      • Sr. Optimization Specialist

        Aug 2022 - Jul 2023
      • Clinical Manager

        Feb 2022 - Aug 2022
      • Associate Clinical Manager

        Aug 2020 - Feb 2022
      • Remote Site Monitor (Level II) & Biotech Logistics Coordinator

        Apr 2018 - Aug 2020
      • Remote Site Monitor (Level I)

        Sept 2016 - Apr 2018
      • Clinical Trial Associate & Project Assistant

        Aug 2015 - Sept 2016
  • Licenses & Certifications

    • Nih protecting human research participants

      The national institutes of health
      May 2013
  • Honors & Awards

    • Awarded to Molly Kaiser (Fahrenkrog)
      PPD Peak Performance Team Award Recipient PPD Global Clinical Development Leadership group May 2017 Quarterly award given to a select few clinical teams at PPD who exemplified achievement of excellent results through extraordinary effort, high standards, and cohesive teamwork
    • Awarded to Molly Kaiser (Fahrenkrog)
      NCUR Oral Research Presenter National Convention of Undergraduate Research Apr 2014
    • Awarded to Molly Kaiser (Fahrenkrog)
      Undergraduate Research and Creativity Grant University of Wisconsin La Crosse Office of Undergraduate Research Sep 2013
    • Awarded to Molly Kaiser (Fahrenkrog)
      Gertrude Salzer Gordon Summer Fellow Gundersen Health System Jun 2013
    • Awarded to Molly Kaiser (Fahrenkrog)
      NCUR Oral Research Presenter National Convention of Undergraduate Research Apr 2013
    • Awarded to Molly Kaiser (Fahrenkrog)
      Wisconsin Board of Regents Presenter, Biology student representitive - Apr 2013
    • Awarded to Molly Kaiser (Fahrenkrog)
      NIH Research Grant National Institute of Health Jan 2012
    • Awarded to Molly Kaiser (Fahrenkrog)
      Deans List Academic Recognition Bruce Riley, Dean of the College of Science and Health