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.
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 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. 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.