Clinical Research Monitor

Weill Cornell Medicine • New York, NY

416d • $84,344 - $98,176

About The Position

The Clinical Research Monitor at Weill Cornell Medicine plays a crucial role in ensuring compliance with institutional and federal regulations in human subjects research. This position involves overseeing quality assurance initiatives, conducting audits, and providing training to ensure data integrity and operational compliance within the research environment.

Requirements

• Bachelor's Degree in a related field.
• Minimum of three years related work experience.
• Extensive technical knowledge of the functioning of IBCs, DSMBs and IRBs, including extensive knowledge of the technical requirements of the federal regulations that govern human subjects research, adverse events reporting, state laws governing research, and WCMC policies.
• Proficient in word processing and database applications.
• Knowledge of Data Safety Monitoring Board (DSMB) operations.
• Prior monitoring/auditing experience.
• Strong analytical and problem solving skills, excellent interpersonal and communications skills, highly organized.

Responsibilities

• Participates in the oversight and monitoring of investigator/coordinator compliance with IRB and institutional requirements and the approved protocol.
• Plans, conducts, and reports internal quality audits, both routine and for-cause, to assure adherence to local and federal requirements.
• Categorizes findings and determines when findings require immediate remedial action; tracks and follows up on corrective and preventive action to ensure continuing data integrity and operational compliance.
• Provides evaluations and summaries of compliance activities to the Assistant Director, and/or stakeholders within the HRPP.
• Assists with compliance training initiatives including coordinating educational sessions, writing and editing compliance manuals, and developing presentations.
• Oversees procedures with regard to performing data management activities, maintain and update computerized databases, create forms, conduct database searches and create reports for various departments listing current research protocols.
• Maintains records and prepares correspondence relating to problems for the DSMB and the IRB.
• Conducts preliminary reviews of all IRB protocols that request the use of DSMB and forwards to the chair for initial review of the Data Safety Monitoring Plan.
• Acts as the WCM DSMB liaison to provide assistance and information to CTSC administrators with regard to the WCM DSMB and adverse event/Unanticipated Problems reporting and procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Educational Services
• Education Level: Bachelor's degree