Naomi Miller Schlabach

Principal Clinical Research Associate Affiliate @Apranik Medtech Consulting, Llc

Sarasota, FL, US

As an Apranik MedTech Consulting affiliate, we specialize in providing clinical Research Services to busy Clinicians/KOLs and small/medium-sized MedTech companies. We are committed to helping you achieve your highest goals. We listen and utilize our training & industry expertise to identify the gaps and strategize the solutions. We stand for our high standards and will never compromise quality, data integrity, and patient safety. We ensure that you are working with experts who are current with the latest regulations, industry standards, and solutions. Our team covers a broad range of disease states and therapeutic areas. Our clinical research associate (CRA) services include-Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines-Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues-Evaluate the quality and integrity of study site practices for successful conduct of the protocol and adherence to applicable regulations-Escalate quality issues as appropriate-Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution-Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator\'s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements-Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters-Collaborate and liaise for project execution support as appropriate.

Kent State University

BSN

University of South Florida

MS

The University of Akron

Health Care Administration and Managment