Clinical Trials Office

Anna C. Pavlick, MS, DO, Medical Director
Erica Love, Administrative Director
Nida Cassim, Associate Director

The CTO is a central office that provides the infrastructure and function for operations of Cancer Clinical Trials at the Perlmutter Cancer Center, an NCI-designated Cancer Center.

CTO personnel are available to both faculty and Industry sponsors to assist throughout the entire lifecycle of a protocol from inception to study closeout. We are the central point of contact who coordinate with Investigational Pharmacy, Laboratory, Nursing, OCT (study contract services), FDA, NCI and other collaborating Academic Institutions.

CTO services include ensuring regulatory compliance, complete IRB services; Protocol and Informed Consent Development; Quality Assurance; Safety monitoring and reporting; Research Nursing; Data Management; Study Budgeting and Clinical Trials Education for faculty and staff. For Investigators wishing to participate in a Clinical Trial the first step is review by the PRMC (Protocol Review and Monitoring Committee).

View information about the Protocol Review and Monitoring Committee (PRMC)

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Regulatory Affairs Unit

The Regulatory Affairs Unit (RAU) consists of both pre-and post-study activation sub-divisions, employs 18 regulatory specialists, 6 of whom focus solely on study activation to support the units rapid activation program, 6 on maintaining regulatory compliance throughout the conduct of a clinical trial and 6 who serve in assistant roles. The regulatory specialists are divided among the DMGs and can facilitate all regulatory submissions.

Contact: Denise Rodriguez, RAU Program Manager (Denise.Rodriguez@nyumc.org)

Data Coordination Unit

The Data Coordination Unit (DCU) is led by four Program Managers who support the DMG clinical research review process, the PRMC initial review process by providing DMG portfolio reports showing how each trial is progressing, and they supervise teams of data managers dedicated to each DMG. The DCU is responsible for reporting trial data in real time.

Contact:
Ankeeta Joshi, Program Manager for Neurology, Gynecology and Hematology (Ankeeta.Joshi@nyumc.org)

Brittany McGough, Program Manager for Thoracic, Melanoma, GI and Head & Neck (Brittany.Mcgough@nyumc.org)

Ethel Yepes, Program Manager for Breast (Ethel.Yepes@nyumc.org)

Martin Donach, Program Manager for GU and Phase 1 (Martin.Donach@nyumc.org)

Quality Assurance Unit

The Quality Assurance Unit (QAU) act as an independent unit, as personnel are not listed as study team members on any protocols, and is focused on maintaining compliance in the conduct of clinical trials at the PCC and the oversight of quality control functions that support the reporting of cancer clinical trial-related data to the DSMC. The QAU consists of a manager, 3 QA specialists, 1 Senior QA nurse, 1 program coordinator that supports the DSMC, and 1 education specialist.

Contact: Fraustina Hsu, QAU Program Manager (Fraustina.Hsu@nyumc.org)

Protocol Development and Monitoring Unit

Protocol Development and Monitoring Unit led by a Program Supervisor, and supported by a Program Coordinator.  This unit works with investigators to ensure that appropriate protocol-specific data and safety monitoring plans are included within each investigator-initiated protocol relative to the study’s risk level and per the PCC’s Data and Safety Monitoring Plan (DSMP), prior to PRMC or IRB submission.

Contact: Audrita Crawford, Program Supervisor (Audrita.Crawford@nyumc.org)

Clinical Coordination Unit

The Clinical Coordination Unit (CCU) is led by a Nurse Manager and two Assistant Nurse Managers, and is made up of both non nurse clinical coordinators and Research Nurses who are responsible for assisting investigators in the recruitment of patients to cancer clinical trials and to assure protocol compliance and high quality clinical documentation.

Contact:
Crystal Escano, CCU Assistant Manager (Crystal.Escano@nyumc.org)
Daniela Delbeau, CCU Assistant Manager (Daniela.Delbeau@nyumc.org)

Business Operations Unit

The Business Operations Unit (BOU) is led by a Business Manager who oversees  financial coordinators responsible for assisting Principal Investigators (PIs) with budget development and negotiation for cancer clinical trials, Medicare Coverage Analyses (MCAs) for those trials, and assurance of billing compliance.

Contact: Lalta Dhanantwari, BOU Manager (Lalta.Dhanantwari@nyumc.org)