West Harrison, New York
Basking Ridge, New Jersey
Newton, New Jersey
Great Falls, Montana
Posted: 07-Jan-25
Type: Full-time
Internal Number: R118800
Job Description
The Research Quality Analyst works under the supervision of Quality Assurance Manager to ensure compliance to all processes contributing to the performance of a clinical trial within the Clinical Trials Office (CTO).
Responsibilities
Performs detailed internal quality checks on essential regulatory files and patients enrolled on a clinical trial applying professional research experience to assess research participant safety, data integrity and research compliance with applicable institutional standard operating procedures (SOPs), Good Clinical Practices (GCP) and all applicable regulations
Recommends necessary steps to resolve any identified compliance issues identified on internal quality checks
Manages corrective and preventative action plans in response to internal/external audits, FDA Inspection or sponsor monitoring visits
Serves as a resource for less experienced colleagues
Develops new quality improvement processes to ensure on-going compliance to quality standards for the conduct of all clinical trials with the CTO
Develops and presents reports to operations managers and CTO directors
Minimum Required Education
Bachelor's degree in scientific discipline, or an equivalent combination of training and experience.
Required Qualifications
1 year of experience in clinical research and/or healthcare-related field. Clinical research certification from an accredited certifying agency desired. Computer skills required with experience using Microsoft Software applications desired. Previous quality assurance experience with clinical trials preferred.
The Ohio State University is one of the nations largest and most comprehensive public universities and a top employer in Ohio.
As one of only 54 designated comprehensive cancer centers in the nation, The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital and Richard J. Solove Research Institute is dedicated to the creation of knowledge in laboratory, clinical and population-based cancer research. We apply those discoveries to develop more effective approaches to cancer prevention, diagnosis, and therapies providing tomorrows standard of care today. A Cancer-Free World Begins Here.
Base Pay: $27.60 / Hour
Research Administration - Research Compliance - Individual Contributor/Specialized - S2 Experienced