Research Committees Specialist

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.

Responsibilities

Independently administers institutional Research Committee operations; Manages committee governance documents, including charters, policies, standard operating procedures, and operational guidance; Prepares, validates, and finalizes committee review materials, recommendations, and related documentation; Oversees committee records, operational metrics, and reporting systems; Serves as 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; Coordinates External Advisory Board activities; Analyzes clinical trial protocols, regulatory documentation, and determines appropriate PRMC review pathway; Evaluates DSMC submissions and manages DSMC submission and review workflows; Collaborates with Disease Working Groups, Quality Assurance Unit, Clinical Research Operations, and other research programs to analyze clinical research metrics and prepare executive reports, dashboards, and presentations

Requirements

Bachelor's degree and 1 year of relevant experience required; Or equivalent combination of education and experience; Fully adheres to applicable safety and/or infection control standards required; Understands and follows data integrity standards and processes required

Nice to have

Ability to effectively manage a higher volume of protocols; Ability to effectively manage moderately complex research protocols/procedures; Possesses a high degree of self-motivation; Recognized ability to function independently; Proficient in managing multiple and competing priorities/demands; Detailed-oriented in record keeping and research documentation; Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation; Strong interpersonal, communication, and organizational skills; Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services; Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet; Demonstrated ability to independently interpret clinical trial protocols, institutional policies, committee operating procedures, and clinical research protocols, and applicable regulations; Ability to effectively utilize research management, database, reporting, and collaboration platforms; Fluent English language skills