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Pauline Johnson, Ccrc Email & Phone Number

Quality Management | Life Sciences at Flatiron Health
Location: New York, New York, United States 6 work roles 1 school
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Current company
Role
Quality Management | Life Sciences
Location
New York, New York, United States
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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.

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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.

Current workplace

Pauline Johnson, Ccrc's current company

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Flatiron Health
Flatiron Health
Quality Management | Life Sciences
200 Fifth Avenue, 8th Floor, New York, New York 10010, us
Website
Employees
501
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6 roles · 16 years

Pauline Johnson, Ccrc work experience

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Senior Manager, Quality | Risk Management

Current

New York, New York, US

Jan 2022 - Present

Manager, Integrated Quality Management -Research Quality Management

New York, New York, US

Jan 2020 - Jan 2022

Lead, Integrated Quality Management

New York, New York, US

Aug 2018 - Jan 2020

Clinical Research Specialist

New York, NY, US

  • 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
Jun 2016 - Jul 2018

Clinical Research Coordinator - Managerial

New York, NY, US

  • 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
May 2014 - Jun 2016

Clinical Research Coordinator

New York, NY, US

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.

2010 - 2014 ~4 yrs
Team & coworkers

Colleagues at Flatiron Health

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1 education record

Pauline Johnson, Ccrc education

  • The City University Of New York
    The City University Of New York
    Biology And Anthropology Dual Major
FAQ

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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