Senior Clinical Research Coordinator

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 at its core is committed to improving the human condition through medical education, scientific research, and direct patient care.

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We have an exciting opportunity to join our team as a Senior Clinical Research Coordinator. The Senior Clinical Research Coordinator (Sr. CRC) is an active participant in all related clinical research studies from research planning and feasibility to completion of all study activities, including direct involvement in pre- and post-activation regulatory maintenance, case management of study participants, lab collection and processing, and data collection.

The Sr. CRC works independently under the general supervision of research management within the CTSI Clinical Research Centers, in collaboration with the Principal Investigator and other study team members, to ensure GCP compliance in the conduct of the study, and adherence to the study protocol. The Sr. CRC provides mentorship to Associate Clinical Research Coordinators and Clinical Research Coordinators and participates in the Clinical Research Centers Orientation Program.

• Adhere to the IRB approved protocol and coordinate protocol related research procedures, study visits, and follow-up care ensuring the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA, and all required obligations to patient/subject, Principal Investigator, Research Team and sponsor and other appropriate agencies.
• Work with licensed clinicians and research managers to develop tracking forms for all active trials, maintain tracking forms throughout the life cycle of the protocol.
• Act as primary point of contact for all assigned studies and patient visits. Coordinate with junior coordinators their schedules for the week.
• Help to reconcile any clinical discrepancies in data with junior coordinators
• Participates in pre-screening and recruitment activities to identify patients that may be eligible for a clinical trial. Trains clinical research coordinators on the process of pre-screening.
• Write research notes in EPIC for specified visits as outlined by the protocol.
• Schedule participants according to the approved protocol; coordinate with ancillary service providers to ensure patients remain adherent to the protocol.
• Helps compile enrollment packet materials to be reviewed and signed by investigators.
• Prepare for study visits: research ticket preparation, lab and EKG orders, scheduling of biopsies and scans, facilitating RECIST form, AE and Conmed form completion in conjunction with licensed professional and other tasks as needed.
• Act as primary point of contact for all bio-specimen collections and participate in the collection, processing, and shipment of laboratory specimens, as per protocol.
• Under the supervision of investigators, assist with the identification, review and reporting of adverse events/serious adverse events/reportable events, protocol deviations, and other unanticipated problems as appropriate.
• Maintain follow up calendar ensuring all follow up assessments are completed per the protocol; performs assessments not requiring licensure.
• May perform EKGs and/or phlebotomy with documented training.
• Under the supervision of licensed clinicians administers ancillary assessments (i.e., Quality of Life questionnaires) and other assessments as approved by PI and study.
• Works with research manager and PI to review, compile, and submit weekly pharmacy lists to investigational pharmacy.

• As applicable, oversee the submission of necessary documents required by the NYU Institutional Review Board (IRB), and any other appropriate parties to obtain approval to conduct human subjects research.
• Participates in the feasibility and complexity assessment process for new protocols.
• Create and place research notes in EPIC
• Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close out activities.
• Coordinate with materials/equipment management to ensure safety of study equipment and monitoring of current inspection stickers when applicable. Coordinates with Sponsor when applicable.
• Responsible for tracking site reimbursement and allocating patient stipends/compensation.
• Preparation and maintenance of study, subject and regulatory…