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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.
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Clinical Operations Manager/Sr. Clinical Operations AssociateOra, Inc. Sep 2019 - PresentAndover, Massachusetts, Us -
Sr. Clinical Trial AssociateOra, Inc. Apr 2018 - Sep 2019Andover, Massachusetts, Us -
Clinical Trial Associate IiOra, Inc. Sep 2016 - Apr 2018Andover, 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 -
Quality Assurance AssociateOra, Inc. Apr 1999 - Apr 2018Andover, Massachusetts, Us -
Regulatory Affairs AssociateBausch & Lomb 1989 - 1996
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Senior SecretaryTextron 1982 - 1987Providence, Ri, Us
Meredith Mayo Skills
Meredith Mayo Education Details
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Northern Essex Community CollegeHealthcare 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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