Clinical Research Coordinator * Must have experience with oncology clinical trials

Position Summary

The Oncology Clinical Research Coordinator (CRC) is an active participant in the coordination of oncology clinical trials from research planning and throughout the conduct of clinical trials. The Oncology CRC performs study coordination tasks under the direction of the principal investigator/treating investigator, under the supervision of the CTO management/leadership and works closely with the Oncology Clinical Research Nurses (CRNs), Oncology Clinical Research Coordinators (CRCs), Data Coordinator Unit (DCU) staff and other CTO and PCC staff to ensure patient safety, overall compliance in the conduct of the study, and adherence to the approved study protocol and quality clinical trial data collection.

• 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 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 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 Con Med 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 Lab Vantage 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…