What are the responsibilities and job description for the Internal Research Monitor position at The Ohio State University Wexner Medical Center?
Job Description
The Clinical Trials Office (CTO) Internal Research Monitor assesses the accuracy and completeness of CTO Investigator Initiated Trials (IITs) and reports findings back to the Data Safety Monitoring Committee (DSMC), applicable research staff and leadership; provides internal monitoring to ensure trials are conducted, recorded and reported in accordance with protocol, US Food and Drug Administration (FDA), Good Clinical Practice (GCP), applicable regulatory requirements, and Standard Operating Procedures; reviews patient medical records and case report forms; provides source data verification; develops and maintains monitoring reporting framework; issues queries regarding monitoring findings to CTO clinical research staff; provides feedback to the DSMC, applicable research staff and leadership regarding monitoring results and may recommend necessary steps to resolve any identified compliance issues; keeps detailed records of all monitoring sessions conducted along with monitoring results, recommendations, and follow-up activities to ensure appropriate action is taken; works in conjunction with the CTO Training Team and CTO Quality Team as needed; participates in writing and implementing Standard Operating Procedures (SOPs) for the CTO; serves as a liaison to the Data Safety Monitoring Committee (DSMC) for any compliance issues; maintains detailed knowledge of applicable University, State, Federal, International regulations and Good Clinical Practice (GCP) guidelines pertaining to research in human subjects.
Minimum Education Required
Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required; Master’s degree in a relevant field desired.
Qualifications
Three to five years of experience in a progressively responsible clinical research or administrative capacity working in clinical research required; considerable knowledge of federal regulatory requirements pertaining to research in human subjects required; considerable clinical research experience strongly preferred; SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) certification required; considerable knowledge of OSU/OSURF policies and procedures preferred.
As one of only 50 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 tomorrow’s standard of care today. A Cancer-Free World Begins Here.
Regular 40 First Shift
