Associate Clinical Research Coordinator

Job Responsibilities:

• Participates in recruitment and pre-screening activities to identify diverse patients who may be eligible for clinical trials. This may include gathering information from the medical record, physician referral, advertisement, and scheduling visits to evaluate the patient/subject. Promptly 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, study related reimbursement etc. (Assessment and medical/nursing education must be performed by a licensed clinician). Ensures patient consent and eligibility is documented in EPIC following institutional and CTO policies.
• Follows relevant institutional and departmental (e.g., NYU, OSR, IRB, & CTO) policies and standard operating procedures to ensure safe, compliant and quality research conduct.
• 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 support 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 (under the supervision of a licensed clinician but clinician does not have to be physically present).
• 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. Coordinates with ancillary service providers to ensure subjects remain adherent to the protocol.
• 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.
• Maintains basic knowledge of research study design and clinical research specimen collection procedures associated with clinical trials. Understands the principles of most research tests performed in research clinical trials. Complete necessary Biological Hazard training provided for the proper handling and collection of biological substances and the packaging and shipment of human biofluid samples.
• Centrifuges, processes, prepares, ships and/or stores biological material in accordance with sponsor protocols, institutional standard operating procedures, Environmental Health and Safety requirements, and universal Biohazard precautions. Performs bench work as needed, may perform advanced specimen processing techniques under direct supervision. Maintain clean laboratory facilities and shared bench spaces.
• Record, update, edit and maintain confidential information related to research biospecimens onto paperwork and/or web-based forms in a neat, accurate and timely manner and ensure subsequent data collection as required. Complete timely correction of queries stemming from inappropriately reported and/or recorded specimen data or missing specimens. Initiate prompt specimen data correction or submission if needed.
• Maintain complete and accurate specimen collection records utilizing enterprise databases for all specimens handled and distributed. Maintain biospecimen files in an organized and up-to-date manner in order to facilitate their retrieval and maintain copies of all required on-going documentation and forms for the files.
• 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 to 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 investigator, may take part in AE and Con Med documentation and reporting activities such as SAE and ECI reports (All documentation must be verified and signed by licensed clinicians before submission and all assessments must be made by a licensed clinician).
• 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.
• Maintain 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 task 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-today-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).
• Coordinates the submission of imaging with the Department of Radiology.
• Performs other duties as assigned and additional responsibilities as needed including but not limited to cross-covering other CCU DMGs as needed.