Clinical Research Monitor - CTSI

Clinical Research Monitor - CTSI

The Ohio State Clinical and Translation Science Institute (CTSI) Research Monitor serves, upon sponsor request, as an independent oversight agent for clinical research trials to ensure the protection of participant safety, data integrity, and regulatory compliance. The monitor is responsible for monitoring the conduct of clinical research trials to ensure trials are conducted, recorded, and reported in accordance with protocol, US Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP), applicable regulatory requirements, and Standard Operating Procedures (SOPs).

The study monitor will assess the accuracy and completeness of the study data and essential records of their assigned trials and reports findings the Sponsor-Investigator, the site PI and their applicable research staff, and other Sponsor-Investigator agents such as the DSMB, Data Manager, Statistician, Funding Agency, and Project Manager. The monitor works in conjunction with the CTSI Training Team, Data and Safety Monitoring Board (DSMB), and the Multicenter Trials Coordination Center (MTCC) and Data Coordination Center (DCC), as applicable.

The study monitor will review and provide feedback on study related documents, such as the study protocol, consent form, case report forms, and the clinical trial monitoring plan; support the study sponsor in the development of the clinical trial monitoring plan; assess adequacy of research facilities/equipment at participating sites; conduct monitoring visits to review essential records, drug/device accountability, and source verification;

assess protocol adherence, adequacy of the informed consent process; and timely recording/reporting of adverse events and other promptly reportable events; issue queries to the study team regarding monitor findings and recommend necessary steps to resolve identified compliance issues; maintain detailed records of monitoring sessions and monitoring results; complete quality and/or audit checks, assist with audit preparation and serve as a liaison during regulatory inspections;

maintain detailed knowledge of applicable university, state, federal, international regulations and good clinical practice guidelines; assist CTSI leadership with writing and implementing CTSI Standard Operating Procedures (SOPs); assist CTSI leadership with developing and maintaining a monitoring framework; assist with developing and presenting research related trainings; assist CTSI leadership with completing outreach to research core services and research colleges and departments;

the monitor may assist CTSI Leadership with clinical trial project management related tasks, such as clinical trial reporting, monitoring trial progress, budgets, contracts, and multi-site management.

The monitor will assist the CTSI with completing regulatory submissions and obtaining regulatory approvals, monitor regulatory progress/status, maintain essential records help coordinate study related meetings, provide regulatory status updates to CTSI Leadership, the Sponsor-Investigator, the participating study sites, and other Sponsor-Investigator agents such as the Data and Safety Monitoring Board (DSMB), Data Manager, Statistician, Funding Agency, and Project Manager.

Minimum Education & Experience Required Candidates must hold a bachelor's degree in biological sciences, health sciences, social sciences, or another medical field, or possess an equivalent combination of education and experience. A master's degree in a relevant field is desired. A minimum of 3 years of relevant experience is required, with 4-6 years preferred. 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, regulatory, and monitoring experience strongly preferred. Clinical research certification from an accredited certifying agency is required to be considered for the position and the certification must be maintained. Requires successful completion of a background check; qualified candidates may be asked to complete a pre-employment physical, including a drug screen.

Experience using various software including Microsoft office, electronic medical records, Electronic Data Capture (EDC) systems, and clinical trial management systems; considerable knowledge of OSU research policies and procedures preferred; previous monitoring experience preferred; requires successful completion of a background check; pre-employment physical including a drug screen.

Function:
Research and Scholarship

Subfunction:
Clinical Research

Band:
Individual Contributor Series-Specialized

Level: S3 Senior

This position may require limited travel (