Research Committees Specialist

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

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 assignments, in accordance with committee policies and established operational procedures.

Clinical Research Leadership Committee (CRLC) specific duties:

• Collaborates with Disease Working Groups, the Quality Assurance Unit, Clinical Research Operations, and other research programs across the institution to analyze clinical research metrics and prepare executive reports, dashboards, and presentations that inform institutional leadership oversight, strategic planning, and CCSG reporting.

Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 1 year of relevant experience required
• Or equivalent combination of education and experience

KNOWLEDGE, SKILLS AND ABILITIES

• Fully adheres to applicable safety and/or infection control standards required
• Understands and follows data integrity standards and processes required
• Ability to effectively manage a higher volume of protocols preferred
• Ability to effectively manage moderately complex research protocols/procedures preferred
• Possesses a high degree of self-motivation preferred
• Recognized ability to function independently preferred
• Proficient in managing multiple and competing priorities/demands preferred
• Detailed-oriented in record keeping and research documentation preferred
• Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation preferred
• Strong interpersonal, communication, and organizational skills preferred
• Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients) preferred
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred
• Demonstrated ability to independently interpret clinical trial protocols, institutional policies, committee operating procedures, and clinical research protocols, and applicable regulations to ensure consistent execution of research oversight activities preferred.
• Ability to effectively utilize research management, database, reporting, and collaboration platforms preferred.
• Fluent English language skills preferred

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.