Clinical Research Monitor

Title: Clinical Research Monitor

Location: Upper East Side

Org Unit: Genetic Medicine

Work Days: Monday-Friday

Weekly Hours: 35.00

Exemption Status: Non-Exempt

Salary Range: $43.68 - $50.77

*As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices

Position Summary

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.

Job 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

Education

• Bachelor's Degree in related field

Experience

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.

Knowledge, Skills and Abilities

• 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.

Licenses and Certifications

Working Conditions/Physical Demands

Cornell welcomes students, faculty, and staff with diverse backgrounds from across the globe to pursue world-class education and career opportunities, to further the founding principle of "any person, any study." No person shall be denied employment on the basis of any legally protected status or subjected to prohibited discrimination involving, but not limited to, such factors as race, ethnic or national origin, citizenship and immigration status, color, sex, pregnancy or pregnancy-related conditions, age, creed, religion, actual or perceived disability (including persons associated with such a person), arrest and/or conviction record, military or veteran status, sexual orientation, gender expression and/or identity, an individual's genetic information, domestic violence victim status, familial status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Cornell University embraces diversity in its workforce and seeks job candidates who will contribute to a climate that supports students, faculty, and staff of all identities and backgrounds. We hire based on merit, and encourage people from historically underrepresented and/or marginalized identities to apply. Consistent with federal law, Cornell engages in affirmative action in employment for qualified protected veterans as defined in the Vietnam Era Veterans' Readjustment Assistance Act (VEVRRA) and qualified individuals with disabilities under Section 503 of the Rehabilitation Act. We also recognize a lawful preference in employment practices for Native Americans living on or near Indian reservations in accordance with applicable law.