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Study Director

AmplifyBio  –  West Jefferson, OH, 43162
... a new state-of-the-art analytical laboratory to include molecular and immunological assays that assess critical safety and ... of the scientific elements of projects to ensure successful implementation and/or study completion of non-clinical studies. ... - May 02

Clinical Trial Medical/ Safety Reviewer

Experis  –  Columbus, OH
... with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; ... responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary ... - May 05

Study Coordinator

Amplifybio, LLC  –  West Jefferson, OH, 43162
... Aligned with, and supported by leading life sciences-focused investors, we partner with our clients to provide preclinical CRO services from single study and through full IND enabling studies. We have a strong focus and commitment to helping ... - May 01

Regulatory Project Coordinator - Regulatory Affairs Administration

Nationwide Children's Hospital  –  Columbus, OH
... the processing, reporting, and special projects for the Office of Research Regulatory Affairs. This position is responsible for maintaining relevant records through the database, and preparing reports on FDA-regulated clinical trial activity. ... - Apr 30

Scientist I, Molecular

Sarepta Therapeutics  –  Columbus, OH
... Support the development and validation of molecular fit-for-purpose clinical and non-clinical biomarkers following the FDA ... Clinical Protocols, Informed Consent, Clinical Study Reports, Investigator Brochures) and documentation for submission to regulatory ... - May 04

Research/Regulatory Nurse Practitioner - Gene Therapy

Nationwide Children's Hospital  –  Columbus, OH
... activities, specifically related to regulatory work, in conjunction with the Clinical Research Coordinators (CRCs) and co ... staff, assists in the writing of FDA Annual Reports, OBA reporting, preparation of DSMB reports, and Clinical Study Reports. ... - Apr 17

Regulatory Project Coordinator - Regulatory Affairs Administration

Nationwide Children's Hospital  –  Columbus, OH, 43215
... the processing, reporting, and special projects for the Office of Research Regulatory Affairs. This position is responsible for maintaining relevant records through the database, and preparing reports on FDA-regulated clinical trial activity. ... - Apr 29

Research/Regulatory Nurse Practitioner - Gene Therapy

Nationwide Children's Hospital  –  Columbus, OH, 43215
... activities, specifically related to regulatory work, in conjunction with the Clinical Research Coordinators (CRCs) and co ... staff, assists in the writing of FDA Annual Reports, OBA reporting, preparation of DSMB reports, and Clinical Study Reports. ... - Apr 16

Clinical Pathology Technician

Amplifybio, LLC  –  West Jefferson, OH, 43162
... to include molecular and immunological assays that assess critical safety and efficacy indicators for cell and gene therapies during preclinical studies AmplifyBio is seeking to hire a Clinical Pathology Technician to join our growing team! ... - Apr 11

Clinical Research Assistant

Ohio State University  –  Columbus, OH, 43201
... compliance to regulatory and sponsor requirements; educates participants of purpose, goals, and processes of clinical study; ... supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), ... - May 05
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