Pauline Johnson, Ccrc Email & Phone Number
Who is Pauline Johnson, Ccrc? Overview
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Pauline Johnson, Ccrc is listed as Quality Management | Life Sciences at Flatiron Health, a company with 501 employees, based in New York, New York, United States. AeroLeads shows a matched LinkedIn profile for Pauline Johnson, Ccrc.
Pauline Johnson, Ccrc previously worked as Senior Manager, Quality | Risk Management at Flatiron Health and Manager, Integrated Quality Management -Research Quality Management at Flatiron Health. Pauline Johnson, Ccrc holds Bachelor Of Science (Bs), Biology And Anthropology Dual Major from The City University Of New York.
Email format at Flatiron Health
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About Pauline Johnson, Ccrc
Senior Manager @ Flatiron Health | Quality Operations - Clinical Quality Management System. Quality professional who ensures integrity and compliance within Clinical Research - RWE/RWD. With over ten years of experience in human subjects research conduct, proactive quality, and compliance in regulated environments; I have developed a strong expertise in Good Clinical Practice (GCP), Risk Based Quality Management, Quality Assurance, Audit and Inspection Readiness, CAPA Management, Risk Assessment, Good Document Practices, and Document Management.My mission is to support the advancement of cancer research and care by enabling the generation of high-quality, real-world evidence that can inform clinical decisions and improve patient outcomes. I am passionate about applying my skills and credentials as a Certified Clinical Research Coordinator (CCRC) and a GCP expert to facilitate the implementation of best practices, standards, and processes across our organization. I am also committed to fostering a culture of quality and continuous improvement among peers, and collaborating with internal and external stakeholders to ensure the alignment of our quality objectives and expectations.
Pauline Johnson, Ccrc's current company
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Pauline Johnson, Ccrc work experience
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Manager, Integrated Quality Management -Research Quality Management
Lead, Integrated Quality Management
Clinical Research Specialist
- Provided the Clinical Research Support Office with assistance to advance the science of regulatory support and compliance. Participated in multi-faceted role which included both study compliance oversight and.
- Conducted not-for-cause and for-cause audits of research protocols to help ensure and provided assurance that all studies were conducted to the highest standards as part of the University's Human Research Protection Plan
- Maintained and Supported an Early audit program which helped new and early stage investigators and their teams achieve the highest level of compliance with Good Clinical Practice and applicable regulations
- Provided guidance to Sponsor-Investigators and University Counsel regarding design and regulations for FDA-regulated Investigation New Drug (IND)/Investigational Device Exemption (IDE) protocols and supported.
- Compiled and maintained metrics of audit findings used to analyze and identify common problems while worked with leadership to investigate and rectify
- Provided administrative oversight to the organization for Protocol Registration and Results System (PRS) on ClinicalTrials.gov
Clinical Research Coordinator - Managerial
- Managed multiple projects while providing excellent judgment of prioritizing support tasks including, but not limited to:
- Management and coordination of Investigator Initiated research projects from inception to closeout
- Study and Site Monitoring to ensure compliance, aligned with Good Clinical Practices (GCP), applicable funding and HHS guidelines (i.e, HIPAA)
- IRB coordination of initial submissions, reporting (amendments, continuing reviews, adverse event and deviations) and closures
- Study coordination of research personnel. Supervised workflow and compliance with regulatory procedures while ensuring that study personnel were IRB approved and properly trained on protocol conduct
- Created and maintained standard operating procedures, study change logs, and data codebooks
Clinical Research Coordinator
Worked on multiple funded studies within the research division of emergency department. Upon leaving, supported two of the division’s highest funded studies: Dr. Corita Grudzen’s American Cancer Society-entitled Emergency Department-Based Palliative Care for Advanced Cancer patients, and the data collection and research arm of the division’s Center for.
Colleagues at Flatiron Health
Other employees you can reach at flatiron.com. View company contacts for 501 employees →
Ryan Hamilton
Colleague at Flatiron HealthKula, Hawaii, United States, United States
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Isabel Dorst
Colleague at Flatiron HealthBerlin, Berlin, Germany, Germany
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Piper Morgan
Colleague at Flatiron HealthCape Coral, Florida, United States, United States
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Whitney Myers
Colleague at Flatiron HealthCharlottesville, Virginia, United States, United States
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Mark Guinter, Phd
Colleague at Flatiron HealthNew York, New York, United States, United States
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Victoria Ritvo
Colleague at Flatiron HealthNew York, New York, United States, United States
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Carlisle Maney
Colleague at Flatiron HealthNew York, New York, United States, United States
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Jessica Greco
Colleague at Flatiron HealthGreater Pittsburgh Region, United States
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Sally Mihovil, Rn
Colleague at Flatiron HealthGreater Houston, United States
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Jose Esquilin
Colleague at Flatiron HealthHouston, Texas, United States, United States
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Pauline Johnson, Ccrc education
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The City University Of New York
Frequently asked questions about Pauline Johnson, Ccrc
Quick answers generated from the profile data available on this page.
What company does Pauline Johnson, Ccrc work for?
Pauline Johnson, Ccrc works for Flatiron Health.
What is Pauline Johnson, Ccrc's role at Flatiron Health?
Pauline Johnson, Ccrc is listed as Quality Management | Life Sciences at Flatiron Health.
Where is Pauline Johnson, Ccrc based?
Pauline Johnson, Ccrc is based in New York, New York, United States while working with Flatiron Health.
What companies has Pauline Johnson, Ccrc worked for?
Pauline Johnson, Ccrc has worked for Flatiron Health, Rockefeller University, New York University, and Mount Sinai Health System.
Who are Pauline Johnson, Ccrc's colleagues at Flatiron Health?
Pauline Johnson, Ccrc's colleagues at Flatiron Health include Ryan Hamilton, Isabel Dorst, Piper Morgan, Whitney Myers, and Mark Guinter, Phd.
How can I contact Pauline Johnson, Ccrc?
You can use AeroLeads to view verified contact signals for Pauline Johnson, Ccrc at Flatiron Health, including work email, phone, and LinkedIn data when available.
What schools did Pauline Johnson, Ccrc attend?
Pauline Johnson, Ccrc holds Bachelor Of Science (Bs), Biology And Anthropology Dual Major from The City University Of New York.
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