Meredith Mayo

Meredith Mayo Email and Phone Number

Clinical Operations Manager at Ora, Inc. @ Ora, Inc.
Meredith Mayo's Location
North Andover, Massachusetts, United States, United States
Meredith Mayo's Contact Details

Meredith Mayo personal email

n/a

Meredith Mayo phone numbers

About Meredith Mayo

Meredith Mayo is a Clinical Operations Manager at Ora, Inc. at Ora, Inc.. She possess expertise in clinical trials, cro, clinical development, fda, gcp and 16 more skills.

Meredith Mayo's Current Company Details
Ora, Inc.

Ora, Inc.

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Clinical Operations Manager at Ora, Inc.
Meredith Mayo Work Experience Details
  • Ora, Inc.
    Clinical Operations Manager/Sr. Clinical Operations Associate
    Ora, Inc. Sep 2019 - Present
    Andover, Massachusetts, Us
  • Ora, Inc.
    Sr. Clinical Trial Associate
    Ora, Inc. Apr 2018 - Sep 2019
    Andover, Massachusetts, Us
  • Ora, Inc.
    Clinical Trial Associate Ii
    Ora, Inc. Sep 2016 - Apr 2018
    Andover, Massachusetts, Us
    • Work to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and government regulations. • Develop protocols, informed consents, source document templates, case report forms, study related logs and Investigator Site File binders• Collect and review site regulatory documents for accuracy and completion (1572, Financial Disclosure documents, CLIA waivers, etc) • Prepare essential documents package to support drug release• Create regulatory packages for IRB submission • Support project management activities including providing meeting minutes/agendas and weekly newsletter to the clinical team, maintaining the study Master Tracker• Assist project managers in preparing study reports and collecting site status updates and study metrics• Co-monitor with CRAs to verify subject safety and site adherence to FDA regulations, ICH/GCP Guidelines, and verify data integrity (as applicable)• Maintain the Trial Master File for clinical projects • QC Trial Master File (for clinical projects where individual is not setting up and maintaining the file)• Provide support to Clinical Operations for implementing process improvement actions, performing bi-annual reviews of applicable SOPs, and conducting departmental training sessions• Assist with Sponsor/IRB audit preparations and participate in response to audit findings
  • Ora, Inc.
    Quality Assurance Associate
    Ora, Inc. Apr 1999 - Apr 2018
    Andover, Massachusetts, Us
  • Bausch & Lomb
    Regulatory Affairs Associate
    Bausch & Lomb 1989 - 1996
  • Textron
    Senior Secretary
    Textron 1982 - 1987
    Providence, Ri, Us

Meredith Mayo Skills

Clinical Trials Cro Clinical Development Fda Gcp Regulatory Affairs Clinical Research Quality Assurance Biotechnology Ich Gcp Life Sciences Protocol U.s. Food And Drug Administration Clinical Monitoring Cro Management Good Clinical Practice Glp Medical Devices Regulatory Submissions Edc Sop

Meredith Mayo Education Details

  • Northern Essex Community College
    Northern Essex Community College
    Healthcare Management/Business

Frequently Asked Questions about Meredith Mayo

What company does Meredith Mayo work for?

Meredith Mayo works for Ora, Inc.

What is Meredith Mayo's role at the current company?

Meredith Mayo's current role is Clinical Operations Manager at Ora, Inc..

What is Meredith Mayo's email address?

Meredith Mayo's email address is me****@****ast.net

What is Meredith Mayo's direct phone number?

Meredith Mayo's direct phone number is +197868*****

What schools did Meredith Mayo attend?

Meredith Mayo attended Northern Essex Community College.

What skills is Meredith Mayo known for?

Meredith Mayo has skills like Clinical Trials, Cro, Clinical Development, Fda, Gcp, Regulatory Affairs, Clinical Research, Quality Assurance, Biotechnology, Ich Gcp, Life Sciences, Protocol.

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