Sorry, this listing is no longer accepting applications. Don’t worry, we have more awesome opportunities and internships for you.

Research Project Manager, CITI - Radiation Oncology Perlmutter Cancer Center Manhattan & Long Island

NYU Winthrop

Research Project Manager, CITI - Radiation Oncology Perlmutter Cancer Center Manhattan & Long Island

New York, NY
Full Time
Paid
  • Responsibilities

    NYU LANGONE HOSPITAL-LONG ISLAND is a 591-bed university-affiliated medical center, which offers sophisticated diagnostic and therapeutic care in virtually every specialty and subspecialty of medicine and surgery. We are a major regional healthcare resource with a deep commitment to medical education and research, offering a full complement of inpatient and outpatient services.

    POSITION SUMMARY: We have an exciting opportunity to join our team as a Research Project Manager, CITI - Radiation Oncology Perlmutter Cancer Center Manhattan & Long Island. In this role, the successful candidate In this role, the successful candidate is responsible for overseeing and coordinating research activities for the Radiology Oncology Department. Responsibilities include preparation of grant applications & submissions, research presentations, manuscript development and leading departmental research meetings. Additionally the candidate is responsible for the development , promotion and direction of clinical trials; regulatory oversight and duties including coordination of submission to the central Institutional Review Board (IRB); overseeing and coordinating the care of active clinical trial participants including trial recruitment, screening and enrollment and performance of study related tasks under the supervision of the Principle Investigator and/or Treating Investigator; collaborate closely with other study personnel to support the safe conduct of clinical trials for oncology patients and ensure overall compliance in the conduct of the study and adherence to the approved study protocol; management of data acquisition, data analysis activities; and manuscript preparation. The candidate manages the study budget, logistics and other supportive functions for the assign projects. This positions requires 25-75% time at the Manhattan based location and up to 25-75% time at the NYU LI based location based on the departmental needs and current protocol portfolio and departmental needs. [at the discretion of the radiology oncology department leadership]

    JOB RESPONSIBILITIES:

    Management of administrative research practices for the Radiology Oncology Department. Ensures assignments are understood and appropriate follow up with management occurs to ensure desired outcomes are reached. Leads weekly departmental meetings including agenda preparation.

     

    Implements any new research Policies and Procedures related to compliance changes or organizational changes to support smooth operations with the management team. Assures compliance with the regulatory mandates of the Joint Commission of Accreditation of Hospitals, New York State Department of Health, CARF, New York City Department of Health, and rules and regulations of the Medical Staff. Establishes systems to communicate any policy or procedural change to all departmental staff and other Medical Center personnel, as required. Utilizes audit results, quality assurance reports and incident reports to improve the quality of service provided. In conjunction with leadership, develops and approves new policies and procedures to improve the effectiveness of the Departmental services.

     

    Budget and Cost Containment - Controls costs by seeking the most effective and efficient means of performing assigned functions. Establishes systems and monitoring to ensure accurate and timely charge entries. Establishes a review/audit system for this process to ensure consistency. Assists in the preparation of the budgets for the clinical trials. Monitors departments operating performance to maintain spending within budgeted resources. Compares actual spending to monthly budgeted amount and explains variances adequately and develops plans of correction.

     

    Regulatory Compliance/Quality Assurance - Responsible for ensuring compliance with regulations. Acts as a liaison with other services for compliance issues. Adequately prepares for periodic inspection by regulatory agencies. Designs and implements and effective departmental quality assurance program; makes periodic changes. Works to educate all management on compliance updates and assists in the development and implementation of training all levels of staff.

     

    Reports/Documentation - Maintains records and prepares reports required by the department.  Enters data and answers queries in sponsor specific electronic database capturing system.

     

    Assists with data analysis, scientific writing and creating and editing of grants, abstracts, manuscripts and presentations.

     

    Statistics experience is ideal particularly with SPSS.

     

    Responsible for the development, promotion, direction and coordination of clinical trials/studies for the Department, including the research design, budget, staffing, logistics and other supportive functions.

     

    Facilitates administration of assigned trial activities to include: managing submission of IRB/Ethics Committee (EC)/national regulatory documents, developing study budgets,

     

    Scheduling and conducting meetings and planning, organizing and coordinating departmental research events and trainings.

     

    Manages and oversees trial start up activities including development/revision of final protocol for Investigator Initiated Trials (IITs), informed consent creation and submission, study manual of operations, Case Report Forms (CRFs) guidelines and study training materials.

     

    Oversees and managed logistics around a new site start-up including activities such as finalizing customized informed consents, finalizing/submitting IRB submissions, submitting IRB amendments, submitting continuing reviews and responding to queries reviewing site regulatory documents etc.

     

    Develops and maintains protocols, SOPs and policies, electronic databases, tracking instruments and forms, data reports, manual cataloging treatments and supports services available to patients and other systems for meeting study outcomes and program deliverables.

     

    Responsible for management, generation, analysis and compiling of study progress reports/metrics for a wide audience. Attends and co-leads training meetings/webinars, team meetings as required.

     

    Ensures accurate execution of research protocols in accordance with Good Clinical Practices (GCP), Health Insurance Portability and Accountability Act (HIPAA), Food and Drug Administration (FDA) and required obligations to patient/subject, Principle Investigator and research team and sponsor.

     

    Trains and educates volunteer Research Associates and ensures all policies and procedures are being adhered to and implemented.

     

    Provide updates to study team members regarding changes to workflow or patient-related specific needs according to protocol modifications. Schedule participants according to the approved protocol; coordinate with ancillary service providers to ensure patients remain adherent to the protocol.

     

    Prepare for study visits: bio-specimen collection 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. May transport investigational product.  Act as primary point of contact for all bio-specimen collections.

     

    Participates in Pre-Screening activities to identify patients that may be eligible for a clinical trial.

     

    Participates in the feasibility and complexity assessment process for new protocols.

     

    Provide patients education on 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 clinician before submission and all assessments must be made by a licensed clinician).

     

    At investigator discretion/DMG discretion: aids in informed consent process by reviewing consent document with patient (Investigators must ensure full understanding of consent document prior to signing and must ensure quality of education provided by Senior CRCs. Investigators may limit Senior CRC ability to help with consent process and must approve individual Senior CRCs to help with consents in order to ensure ongoing quality of consent process. Write research notes in EPIC (may not make assessments).

     

    Helps compile enrollment packets (must be reviewed and signed by investigator).

     

    Serves as the department liaison to the Clinical Trials Office. Serves as a liaison to support interdepartmental collaboration for oncology clinical trials and research activities.

     

    Additional responsibilities as needed including: Help in the development of SOPs, policy changes, education sessions, and quality improvement projects.

     

    Performs other duties as required.

    MINIMUM QUALIFICATIONS: To qualify you must have a Bachelors degree in health care administration or a related field. 3 - 5 years of related experience coordinating clinical/research trial studies. Collaborative Institutional Training Initiative (CITI).. REQUIRED LICENSES: Collaborative Inst Trng-Cert

    PREFERRED QUALIFICATIONS: Masters Degree in health care administration or related discipline is preferred Certified Clinical Research Professional (CCRP) 4 years experience in research or related field

    Qualified candidates must be able to effectively communicate with all levels of the organization. NYU Langone Hospital-Long Island provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. NYU Langone Hospital-Long Island 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. If you wish to view NYU Langone Hospital-Long Island's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information. To view the Pay Transparency Notice, please click here.

    Required Skills Required Experience