Clinical Research Monitor

Weill Cornell Medical College•New York, NY

3d•Onsite

About The Position

The Clinical research monitor, under the guidance of the Assistant Director of Human Research Compliance, will assist in the implementation and day-to day operations of all quality assurance and improvement initiatives for the WCM, including the audits, Data Safety Monitoring Board, and education programs.

Requirements

Bachelor's Degree in 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 and ability to act as a role model for staff.

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
Oversee 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.
Maintain records and prepare correspondence relating to problems for the DSMB and the IRB.
Conduct preliminary reviews of all IRB protocols that request the use of DSMB and forward 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.
Serve as ESCRO adminsitrator