Rachel Pop

Experience

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  Jacksonville Center for Clinical Research

  May 2012 - Jun 2017

  Project Manager for over 25 Clinical Trials, Following: ICH E6/ Good Clinical Practice, Standard Operating Procedures and Protocol, Protocol Training and Managing study staff, Maintaining Trial Masters Files, Regulatory Submissions to IRB, Conducting: Site Selection Visits, Site Initiation Visits, Monitor Visits, Close Out Visits, Sponsor Audits and patient visits, Patient Case Management, Consenting Patients, Collecting Data per Protocol, Documenting: Adverse Events, SAE's, Unanticipated Events, SUSAR's and Endpoints, Data Management to meet timelines for database locks, IP Accountability and Inventory IP Dispensation and Disposition, Laboratory Processing, Lab kit Preparation, Recruiting and Soliciting Patients, Mentoring Research Assistants.Clinical Trial Experience with Monoclonal Antibodies and Immunotherapies.Therapeutic areas of study: 1. Cardiovascular (Heart Failure, Angina, Peripheral Artery Disease, Hypercholesterolemia, Exercise Treadmill Testing, Cardiopulmonary Testing, Ankle Brachial Index with Doppler Ultrasound)2. Osteoarthritis3. Neuropsychiatric (SCID, DSM-V, CSSRS)4. Sarcopenia (Exercise Testing)5. Vaccines 6. Type 2 Diabetes Mellitus (Oral Glucose Tolerance Testing) Show less

  • Certified Clinical Research Coordinator

    May 2012 - Jun 2017

  • Clinical Research Coordinator

    May 2012 - Aug 2012
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  East Coast Institute For Research

  Jun 2017 - Sept 2017

  Senior Research Coordinator/ Regulatory Specialist

  Senior Project Manager of Gastroenterology clinical trials, Maintaining Trial Master Files for all studies at the site, Submitting Regulatory Documents to the IRB (1572, Protocol Investigator Signature page, IB Investigator Signature, Confidentiality and Disclosure Agreement, Periodic and Continuing Reports, Adverse Event Reporting, Unanticipated Problem Reporting, Site Closure), Medical Records Review, Recruiting and Soliciting patients, Business Development with GI offices, mentoring coordinators. Therapeutic Areas: Crohn's Disease and Ulcerative Colitis. Show less

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  Self

  Sept 2017 - Jul 2018

  Clinical Research Contractor

  Contracted for various positions including: Clinical Trials Operations Manager, SOP Consultant/ Writing, Creating New Hire Training Program, Business Start-up, Obtaining City Permits.

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  Mayo Clinic

  Jul 2018 - Oct 2021

  Managed over 35 clinical research coordinators in cross-functional research teams in oncology trials (solid tumor, hematology, CAR-T Cell Therapy) to evaluate staff performance. Involved in study start-up with legal and contracts, budgeting and developing time and tasks for budget analysis, Managed financial, study portfolios for over 15 Principal Investigators. Participated in quarterly finance meetings for budget evaluations and sustainability. Completed bi-weekly staff effort reporting and monthly certification. Conducted monthly quality, clinical monitoring of Investigator Initiated Trials and NIH Cooperative Group Trials. Identified areas for process improvement and implementing change management. Therapeutic areas in Oncology: CAR-T Cell Therapy, Breast, GYN, Head & Neck, Sarcoma, Lung, GU, Lymphoma, Multiple Myeloma/ CLL, Melanoma. Show less Team Lead across multiple oncology teams (phase 1 unit, solid tumor, hematology, cell therapy) while coordinating phase 1 oncology trails. Ensured adequate staff coverage, managed timecards and PTO, overseeing staff adherence to institutional policies and SOP's. onboarded, trained and mentored new hires. Developed a three-week New Hire Training Program in collaboration with an Educational Specialist. Conducted monthly quality, clinical monitoring for Investigator Initiated Trials and NIH Cooperative Group Trials. Show less Specializing in Oncology Phase 1 clinical trials; Clinical Research Coordinator overseeing the daily operations of assigned Phase 1 oncology trials. Managed studies from site selection visits, maintenance to close-out. Participated in bi-annual auditing and monitoring with Compliance Office, for oncology Investigator Initiated Trials. Therapeutic areas of experience: B-cell malignancies (Multiple Myeloma, Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, Acute Myeloid Leukemia, Waldenstrom Macroglobulinemia) Show less

  • Supervisor - Cancer Clinical Studies Unit

    Nov 2020 - Oct 2021

  • Team Lead - Lead Certified Clinical Research Coordinator

    Nov 2019 - Nov 2020

  • Certified Clinical Research Coordinator-Oncology

    Jul 2018 - Nov 2020
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  PPD

  Oct 2021 - Sept 2022

  Clinical Team Manager - Oncology

  As a Clinical Team Manager, drives and owns the clinical deliverables at a project level ensuring timelines, resources and quality are maintained and adequate; provides project-specific training, leadership and therapeutic knowledge to the clinical team to achieve project goals and maintain motivation; development of monitoring strategy at project level accounting for potential risks and bringing solutions when issues arise; utilizes data sources available to proactively identify emerging risks; forecasts and reconciles clinical budget in accordance with scope, proactively identifying and partnering with Project Lead and sponsor to address and out of scope tasks; collaborates with Project Lead, Project Functional Leads and other stakeholders to prepare, organize and present during internal and external meetings. Show less

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  The Janssen Pharmaceutical Companies of Johnson & Johnson

  Sept 2022 - now

  Manager, US Medical Affairs CAR-T