Associate Clinical Research Coordinator - NYU Langone Medical Center

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. At NYU Langone Health, equity, diversity, and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace diversity, inclusion, and individual skills, ideas, and knowledge. For more information, go tomed.nyu.edu, and interact with us onLinkedIn,Glassdoor,Indeed,Facebook,TwitterandInstagram.

Position Summary:

We have an exciting opportunity to join our team as an Associate Clinical Research Coordinator.The Oncology Associate Clinical Research Coordinator (aCRC) is an active participant in the coordination of oncology clinical trials from research planning and throughout the conduct of clinical trials. The Oncology 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 the Oncology Clinical Research Nurses (CRNs), Oncology Clinical Research Coordinators (CRCs), Data Coordination Unit (DCU) staff and other CTO and PCC staff to ensure patient safety, overall compliance in the conduct of the study, adherence to the approved study protocol and quality clinical trial data collection.

Job Responsibilities:

Participates in recruitment and pre-screening activities to identify diverse patients who may be eligible for clinical trials. 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, 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 in collaboration with the CCU team 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).

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, 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/treating investigator and CTO management/leadership and in collaboration with the team.

Provides timely updates to study team members regarding changes to workflow or patient-related needs according to protocol modifications.

Communicates effectively with patients and investigators 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; coordinates subject’s tests and procedures in compliance with the particular protocol and with the appropriate department, and collaborate 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.

Maintains a working knowledge of active and pipeline clinical trials within the DMG and regularly updates the DMG schemas.

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; assure patient assignments are aligned with protocol requirements; make necessary requests for changes on as-needed basis.

May perform EKGs with documented training.

Performs concomitant medication review including reconciliation of the medication list, 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.

Maintain 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. 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.

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.

Reconcile 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 competence in utilizing the LabVantage system.

Responsible for quality source documentation following ALCOA-C standards (attributable, legible, contemporaneous, original, accurate and complete) and compliant with CTO specific documentation.

Protect patient confidentiality and PHI and comply with HIPAA.

Competency 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).

Performs other duties as assigned and additional responsibilities as needed including but not limited to cross-covering other CCU DMGs as needed.

Minimum Qualifications:

To qualify you must have anAssociate's Degree.Computer literate with good interpersonal, writing and verbal communication skills.1-year experience in a healthcare related position required, relevant experience determined at the discretion of the Administrative Director, Clinical Operations.Proficiency in using various Microsoft Office applications such as Word, Excel, Access, Power Point and Outlook. Familiar with Internet applications.Intermediate competency in medical terminology, and Good Clinical Practice (GCP) guidelines, Federal Regulation that govern the conduct of human subjects research as well as Institutional Review Board and institutional policies and procedures related to human subjects research.
Proficient analytical, interpersonal, writing and verbal communication skills.The ability to manage priorities and deadlines and maintain service level expectations for tasks. Adaptability, independently completes tasks and works within deadlines and collaborate effectively as part of a team.Commitment to team problem-solving approach using a research and patient-focused model. Ability to identify, analyze and solve problems.Ability to multi-task and prioritize in a fast-paced work environment, time management skills and an ability to work well under pressure.Organizational skills both to function independently and as a member of a professional team.Ability to work with diverse groups of people.Effective oral, written, communication, interpersonal skills.Must be able to work under the direction of supervision.

Preferred Qualifications:

Bachelors degree, preferably in science, public health, health education or a related field.Professional certification (ACRP CCRC or SOCRA CCRP). Individuals without this certification are encouraged to obtain this certification within one year of starting in the Associate CRC role.1-2 years experience in research or related experience preferred.Experience in oncology setting preferred.Experience with EPIC EHR preferred.

Qualified candidates must be able to effectively communicate with all levels of the organization.

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NYU Grossman School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online.
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NYU Langone Health provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $62,400.00 - $69,628.00 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

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