Competent in all recruitment and pre-screening activities identifying diverse patients who may be eligible for clinical trials. Promptly follows up pre-screening requests and iConnect requests within 24 business hours. Supports the training and mentorship of aCRCs in learning these tasks.
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, through the consenting process, through the screening period and to eligibility. Supports thorough, efficient and safe screening research visit(s) in collaboration with the CRNs and 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 the PI/Sib-I review and sign-off.
Supports the informed consent discussion with the subject under the direct supervision of the PI/treating investigator and/or in collaboration with the CRN 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). Supports the training of aCRCs in these tasks.
Follows institutional and department policies and standard operating procedures such as relevant NYU, OSR, IRB and CTO policies, procedures and standard operating procedures to ensure safe, compliant and quality research conduct.
Demonstrates understanding of protocol elements and requirements. Collaborates with CRCs and CRNs to develop tracking forms for all active trials, maintain 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 timely and complete updates to study team members regarding changes to workflow or patient-related specific needs according to protocol modifications.
Communicates effectively with patients about non-clinical study related concerns such as the schedule of events, trial related reimbursement or transportation.
Schedules study participants according to the approved protocol; coordinates with ancillary service providers to ensure patients remain adherent to the protocol; coordinate subject’s 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 patients remain adherent to the protocol.
Prepares for study visits: research bio-specimen collection order preparation/placement, laboratory and EKG order placement, scheduling of biopsies and scans, facilitating RECIST form completion from the investigator, AE and ConMed form completion in conjunction with a licensed professional (CRN/APP/MD) and other tasks as needed to support the administrative conduct of clinical trials. Supports the training and support of the aCRC in the team for these tasks.
Maintains a working knowledge of active and pipeline clinical trials within the DMG and regularly updates the DMG schemas. Oversees that the DMG schema is maintained up-to-date on a monthly basis and trains aCRCs in this task.
Understands adverse event reporting per protocol and per institutional and FDA guidelines including AE, SAE, ECI, UADE, SUSAR and RNI.
Maintains trackers to ensure patients remain compliant with study specific requirements and tasks.
Follows CTO processes and policies for treatment clearance and supports effective, clear communication.
Acts as primary point of contact for all bio-specimen collections. Utilizes EPIC and LabVantage to complete research biospecimen orders in a timely manner.
Compiles and submits weekly patient treatment lists to investigational pharmacy and RBMU and other departments as needed.
Monitors infusion chair assignments; ensures patient assignments are aligned with protocol requirements; make necessary requests for changes on as-needed basis.
May perform EKGs with documented training. Ensures that all study specific EKG machines are tracked and maintained within the DMG safely and securely. Takes initiative to address any sponsor EKG machines issues in a timely manner. Oversees the documentation and inventory of DMG study equipment.
verification of drug/dose taken and diary review if applicable, appropriate documentation in EPIC and via the study specific diary 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.
Initiates vial assignment and coordinates with Infusion Nurses and Pharmacy to ensure timely dispensation of IP per CTO processes/policies.
Self-audits one’s own work to ensure protocol compliance and patient safety.
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. Proficiently 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. Supports feasibility for complex trials and trains aCRCs in preparation for study start up.
Provides updates to study team members regarding changes to workflow or patient-related specific needs according to protocol modifications.
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.
Takes the lead on reconciling clinical discrepancies and queries in a timely manner in collaboration with the CCU and DCU team members.
Demonstrates competence in Good Clinical Practice (GCP) guidelines, Federal Regulations that govern and conduct human subject’s research and the NYU IRB policies and procedures related to Human Subject’s research. Perform study operational activities and task in compliance with GCP, Federal Regulations and institutional policies and procedures.
Prepares for upcoming study visits including but not limited to biospecimen collection research tickets/orders, laboratory and EKG orders, scheduling requests, interpreter requests, assessment form completion, QOLs, sharing EPIC smart-phrases and other tasks as needed to support a seamless, safe, compliant clinical research visit per protocol. Demonstrates proficiency in utilizing the LabVantage system and trains aCRCs on the system.
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 comply with HIPAA.
Competent in utilizing CRMS and Research Navigator for day-to-day tasks: including but not limited to always checking that participating PIs/Sub-Is and staff are on listed on study with the IRB prior to upcoming clinical trial visits/activities.
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.
Assists patients in understanding the schedule of assessments according to the approved protocol, coordination of appointments, and ancillary services (under the supervision of a licensed clinician but clinician does not have to be physically present).
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).
Writes research notes in EPIC to support clear clinical trial documentation (may not make assessments).
Cross-covers other CCU DMGs as needed.
Supports and contributes to the development of tools and workflows to improve the efficiency of the CCU DMG. Takes initiative to resolve protocol/sponsor related concerns and discrepancies. Engages in problem solving and generating solutions to barriers and opportunities for improvement.
Performs other duties as assigned and additional responsibilities as needed including but not limited to: supporting the development of SOP’s, policy changes, education sessions, and quality improvement projects.