Associate Clinical Research Coordinator * Must have clinical research experience *

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine is committed to improving the human condition through medical education, scientific research, and direct patient care.

About the role

The Non-therapeutic Oncology Associate Clinical Research Coordinator (NT aCRC) is an active participant in the coordination of oncology clinical research studies from research planning and throughout the conduct of clinical studies on various existing and upcoming protocols. The NT aCRC performs study coordination tasks under the direction of the principal investigator/treating investigator, under the supervision of CTO management/leadership, and works closely with CTO staff, PCC staff, and other service-rendering departments to ensure patient safety, overall compliance in the conduct of the study, adherence to the approved study protocol, and quality clinical trial biospecimen and data collection. The NT aCRC interfaces directly with the Principal Investigators, various departments, research teams, and sponsors in support of the clinical trials as applicable.

Responsibilities

• Participates in recruitment and pre-screening activities to identify diverse patients who may be eligible for clinical trials, including gathering information from the medical record, physician referral, advertisement, and scheduling visits to evaluate the patient/subject.
• Follows up pre-screening requests and iConnect requests within 24 business hours.
• Collaborates with investigators, CTO staff, and NYU/PCC staff to ensure a safe, compliant screening process by supporting seamless navigation of patients onto study from pre-screening, consenting, through the screening period, and to eligibility.
• Supports thorough, efficient, and safe screening research visit(s) under the direct supervision of the PI/investigator.
• Supports a safe and compliant eligibility process, following internal and external SOPs/policies, and ensuring a timely, accurate, and complete eligibility packet for PI/Sub-I review and sign-off.
• Supports and conducts the informed consent process, if delegated, with the subject under the direct supervision of the PI/treating investigator, including but not limited to: the study schedule of events, event reporting requirements, the use of the IRB, and study-related reimbursement.
• Ensures patient consent and eligibility are documented in EPIC following institutional and CTO policies.
• Registers/Randomizes subjects according to protocol and internal CTO policies.
• Demonstrates understanding of protocol elements and requirements. Develops tracking forms for all active trials, maintains tracking forms throughout the life cycle of the protocol, and supports a double check of tracking forms for patient safety and quality data acquisition.
• Performs study-specific procedures and tasks under the supervision of the Principal Investigator and CTO management/leadership and in collaboration with the team.
• Provides updates to study team members regarding changes to workflow or patient-related needs according to protocol modifications.
• Communicates effectively with patients and assists them in understanding/navigating non-clinical study-related concerns such as the schedule of events, trial-related reimbursement or transportation, and ancillary services.
• Schedules study participants according to the approved protocol; coordinates with ancillary service providers to ensure patients remain adherent to the protocol; coordinates subjects' tests and procedures in compliance with the particular protocol and with the appropriate department, and collaborates with other NYU and PCC departments to seamlessly navigate a patient to a trial and through screening, treatment, and follow-up/end of treatment.
• Prepares for upcoming study visits: research bio-specimen collection order preparation/placement, laboratory and EKG order placement, scheduling of biopsies and scans, interpreter requests, facilitating tumor assessment form completion from the investigator, QOL, AE, and ConMed form completion in conjunction with a licensed professional (CRN/APP/MD), and other tasks as needed to support seamless, safe, and compliant clinical research conduct per protocol.
• Acts as a primary point of contact for all bio-specimen collections to include providing patients with specimen collection kits, collecting specimens, arranging for couriers, and coordinating tissue acquisition as required per protocol. Utilizes EPIC and LabVantage to complete research biospecimen orders in a timely manner. Coordinates the submission of imaging with the Department of Radiology.
• Collects patient information for research project(s) to include, but not limited to: abstracting data from the patient chart (e.g., laboratory or diagnostic test results, surgical/radiation treatments delivered, adverse drug reactions, etc.), abstracting data for publications, or collecting data from outside physicians' offices.
• Enters study data and resolves queries on all assigned studies. Uses tools to facilitate data collections (e.g., calendars, tracking logs, etc.). Audits and updates the database and/or case report forms.
• Gathers and compiles data and assists in consolidating/analyzing data for presentation to sponsoring and regulatory agencies. Provides reports to all necessary parties (e.g., the PI, sponsoring agency, etc.) on the progress of the study as needed. Conducts primary analysis of data collected. Formulates, develops databases, and generates preliminary measurement reports for review by the PI on various existing and upcoming protocols.
• Competency in utilizing CRMS and Research Navigator for day-to-day tasks including but not limited to: checking that participating PIs/Sub-Is and staff are listed on study with the IRB prior to upcoming clinical trial visits/activities and logging study visits into CRMS as they occur to ensure study sponsors are billed for research procedures in a timely and efficient manner.
• Schedules monitoring visits as needed. Coordinates the visit with the study monitor, the CTO Administrative Assistant, and Vornado Realty Trust. Requests charts and access to the Electronic Medical Record for study monitors and records all visits in the Data Coordination Unit (DCU) SharePoint. Communicates the change of a monitor, or additional monitors on site, to the Business Operations Unit (BOU) for billing purposes.
• Maintains a working knowledge of active and pipeline clinical trials within the DMG and regularly updates the Non-therapeutic section of the DMG schema.
• Understands and coordinates the submission of adverse events per protocol and per institutional and FDA guidelines including AE, SAE, ECI, UADE, SUSAR, and RNI. Under the supervision of the investigator, may take part in AE and Con Med documentation and reporting activities such as SAE and ECI reports.
• Maintains trackers to ensure patients remain compliant with study-specific requirements and tasks. Compiles and submits weekly patient lists to RBMU and other departments as needed.
• May perform EKGs with documented training.
• Performs concomitant medication review including reconciliation of the medication list, appropriate documentation in EPIC following SOP under the direction of the investigator or in collaboration with a licensed RN/APP.
• Maintains a clear, clean follow-up calendar for the CCU DMG team ensuring all survival follow-up assessments are completed per the protocol.
• Conducts a protocol feasibility assessment per institutional guidelines and utilizing CTO-specific resources and guidance documents. Appropriately escalates and informs CTO/CCU management and leadership of feasibility barriers for protocols under review.
• Supports study activation for the CCU DMG including but not limited to ensuring that when a clinical trial is activated in the DMG all necessary elements are in place for a safe, compliant study start-up.
• Attends DMG and CTO meetings to support patient care, quality research conduct. Attends tumor board and/or clinical meetings to support recruitment of patients to trials. Tracks pre-screening patient requests as needed within the DMG.
• Demonstrates competence in Good Clinical Practice (GCP) guidelines, Federal Regulations that govern and conduct human subjects research, and the NYU IRB policies and procedures related to Human Subjects research. Performs study operational activities and tasks in compliance with GCP, Federal Regulations, and institutional policies and procedures.
• Responsible for quality source documentation following ALCOA-C standards (attributable, legible, contemporaneous, original, accurate, and complete) and compliant with CTO-specific documentation. Protects patient confidentiality and PHI and complies with HIPAA.
• Demonstrates self-auditing of own work to ensure protocol compliance and patient safety. Respectfully reconciles any clinical or data discrepancies and queries in a timely manner in collaboration with CTO team members.
• Utilizes principles of HRO in day-to-day work and communication to ensure safe, quality clinical research conduct.
• Supports internal audits and preparation for external audits as needed across the CTO.
• May write research notes in EPIC to support clear clinical trial documentation (may not make assessments).
• Performs other duties as assigned and additional responsibilities as needed including but not limited to cross-covering other CCU DMGs as needed.

Requirements

• Bachelor's Degree or equivalent combination of education and experience required.
• Computer literate with good interpersonal, writing, and verbal communication skills.
• 1 year of relevant experience required.
• Effective oral, written communication, and interpersonal skills.
• Must be able to work under the direction of supervision.
• Ability to identify, analyze, and solve problems.
• Time management skills and ability to work well under pressure.
• Proficiency in using various Microsoft Office applications such as Word, Excel, Access, PowerPoint, and Outlook. Familiar with Internet applications.

Preferred Qualifications

• Bachelor's degree, preferably in science, public health, health education, or a related field.
• Experience in an oncology setting preferred.
• Professional certification (ACRP CCRC or SOCRA CCRP). Individuals without this certification will be encouraged to obtain this certification within one year of starting in the CRC role.
• 2 years of experience in research or related experience preferred.
• Qualified candidates must be able to effectively communicate with all levels of the organization.