Cancer Clinical Trials Office Operational Units | NYU Langone Health

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Perlmutter Cancer Center Clinical Trials Office Cancer Clinical Trials Office Operational Units

Cancer Clinical Trials Office Operational Units

The Clinical Trials Office at Perlmutter Cancer Center has several operational units that perform specific functions to support investigators and their clinical trials. This includes quality assurance, regulatory affairs, business operations, clinical coordination, and data coordination.

Protocol Development and Monitoring Unit

The Protocol Development and Monitoring Unit supports translational researchers by providing protocol development services, including writing and filing U.S. Food and Drug Administration Investigational New Drug and Investigational Device Exemption submissions. For more information about quality assurance protocols, contact Audrita Crawford, protocol development specialist, at audrita.crawford@nyulangone.org.

Quality Assurance Unit

Our specialists in the Quality Assurance Unit conduct central monitoring of both single- and multisite Perlmutter Cancer Center investigator-initiated trials. In collaboration with DataCore, our staff ensures high-quality and timely submission of data to the Data and Safety Monitoring Committee. We also conduct quarterly internal audits and routine monitoring of single- and multisite investigator-initiated trials.We provide centralized training and education to staff and physicians who conduct cancer clinical research. Our quality assurance specialists work with the education specialists to deliver tailored outreach, training, and education based on internal monitoring and auditing findings. For more information about training and education, contact Diane Cozadd, education specialist, at diane.cozadd@nyulangone.org.

For general questions about clinical trial quality assurance, email us at PCC-QAU@nyulangone.org.

Regulatory Affairs Unit

The Regulatory Affairs Unit is responsible for the efficient, compliant, and timely activation of national cooperative group, externally peer-reviewed, and industry- and investigator-initiated clinical trials. We also support investigators to maintain regulatory compliance throughout the duration of a clinical trial.

For more information about regulatory affairs for clinical trials, email us at PCC-RAU@nyulangone.org.

Business Operations Unit

The Business Operations Unit helps investigators conduct Medicare coverage analyses and develop funding plans for clinical trials. We also ensure appropriate funding is available for each clinical trial through budget development and negotiation and help maintain clinical research billing compliance.

For more information about business operations, email us at PCC-BOU@nyulangone.org.

Clinical Coordination Unit

The Clinical Coordination Unit is composed of clinical research coordinators and research nurses who are responsible for assisting investigators to assess the feasibility of new clinical research opportunities. Our staff maintains an in-depth understanding of the study protocol to ensure the safe enrollment of patients in cancer clinical trials and compliance with study protocol–defined procedures.

Our research nurses provide specialized care coordination and symptom management to our research patients, serving as a central contact for both the patient and the patient’s family during their participation in a clinical trial.

For more information about clinical coordination, email us at PCC-CCU@nyulangone.org.

Data Coordination Unit

The Data Coordination Unit provides real-time submission of study case reports forms and ongoing customer service to our study sponsors and collaborators. Data coordinators facilitate monitoring visits and ensure that all data queries are resolved in a timely manner.

For more information about data coordination, email us at PCC-DCU@nyulangone.org.

Research Biofluid Management Unit

The Research Biofluid Management Unit provides biofluid processing support services to Perlmutter Cancer Center investigators. Our staff manages lab kit preparation and delivery, specimen collection, and the processing and shipment of biofluid specimens to central labs. Our services include the following:

  • coordination of the collection, processing and shipping, or storage of biofluid samples for cancer clinical trials supported by the Perlmutter Cancer Center Clinical Trials Office (i.e., samples collected for industry initiated or investigator initiated interventional therapeutic trials)
  • coordination of study lab kit provision to external subsites, and the return, processing and/or storage of biofluid samples collected at Perlmutter Cancer Center investigator-initiated trial subsites for interventional therapeutic trials
  • research biofluid specimen support for other hypothesis driven clinical research centrally supported by the Perlmutter Cancer Center Clinical Trials Office that require biofluid sample collection (i.e., noninterventional studies)

For more information about the Research Biofluid Management Unit, email us at PCC-RBMU@nyulangone.org.