Research Committees Specialist

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Job Location (Full Address):

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400178 Cancer Center/Clin Trials Ofc

Work Shift:

UR - Day (United States of America)

Range:

UR URG 108 H

Compensation Range:

$25.14 - $35.24

Responsibilities:

The Clinical Research Regulatory Support Specialist II independently administers the Wilmot Cancer Institute's clinical research oversight committees for cancer-relevant clinical trials conducted throughout the University of Rochester. The position exercises independent judgment in interpreting and applying National Cancer Institute Cancer Center Support Grant (CCSG) requirements, institutional policies, committee procedures, and applicable regulations to ensure institutional compliance and the integrity of cancer center research oversight processes. The incumbent serves as the primary liaison among investigators, committee leadership, research administration, and institutional stakeholders to ensure efficient, compliant execution of committee review and institutional oversight activities.

ESSENTIAL FUNCTIONS

General Duties:

• Independently administers institutional Research Committee operations, ensuring committee activities are executed in accordance with committee charters, institutional policies, and CCSG requirements.
• Manages committee governance documents, including charters, policies, standard operating procedures, and operational guidance, ensuring alignment with institutional and regulatory requirements.
• Prepares, validates, and finalizes committee review materials, recommendations, and related documentation to develop final materials for committee review and determinations.
• Oversees committee records, operational metrics, and reporting systems to ensure fulfillment of institutional oversight and CCSG reporting requirements.
• Serves as the primary resource and liaison for investigators, faculty, and research staff regarding Research Committee policies, protocol submission requirements, review processes, and committee procedures.
• Designs, implements, and continuously improves Research Committee operational processes, workflows, forms, and guidance documents to improve efficiency, consistency, and regulatory compliance.
• Coordinates External Advisory Board activities to support institutional compliance with CCSG requirements.

Protocol Review and Monitoring Committee (PRMC) specific duties:

• Analyzes clinical trial protocols, regulatory documentation, investigator submissions, National Cancer Institute (NCI) guidance, institutional policies, and committee procedures to identify deficiencies and determine readiness for committee review.
• Determines the appropriate PRMC review pathway based on protocol characteristics, committee policies, and established operational precedent; coordinates reviewer assignments with the PRMC Chair.
• Evaluates protocol amendments and recommends the appropriate review pathway in accordance with the nature and significance of the proposed changes.
• Analyzes protocol accrual and performance data; prepares operational reports used by committee leadership to track and monitor protocol oversight activities.

Data and Safety Monitoring Committee (DSMC) specific duties:

• Evaluates DSMC submissions for completeness, required safety reporting, protocol-specific monitoring requirements, and compliance with DSMC policies before committee review.
• Manages DSMC submission and review workflows to ensure required data, investigator reports, and safety information are complete and available for committee review in accordance with the DSMC/DSMP.
• Determines submission readiness and coordinates DSMC review activities, including reviewer