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Senior/Clinical Research QA Specialist - Pulmonary Medicine

Cincinnati Children's Hospital • Cincinnati, OH, US • published 2026-09-26 03:51:38.582803

Description

Primary Location Location R Department Pulmonary Medicine Shift Day (United States of America) Schedule Full time Weekly Hours 40 FTE 1 Employee Status Regular JOB RESPONSIBILITIES Data and Documentation \- Review and analyze clinical trial data and related documentation (internal and external). Provide guidance to clinical faculty and staff in clinical research documentation. Develop monitoring plans with indicators of quality, reliability, and adherence to SOPs. Develop and communicate outcome measures. Protocols \- Provide input into the development of new protocols and plans for implementing new trials as requested by Principal Investigators/Managers. Coordinate the development of regulatory sections of investigator\-led protocols, e.g., data safety monitoring plans. Develop and maintain SOPs for clinical trials. Act as a primary resource on an ongoing basis for clinical trials staff, responding to questions and issues pertaining to study documentation, GCP, or other issues as requested. Oversee documentation of monitoring visits and report status for leadership and investigators. Monitoring \- Develop comprehensive data safety monitoring plans for all clinical trial activities...

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