Oncology Clinical Research Coordinator III

Position Summary:

Rutgers, The State University of New Jersey is seeking a Oncology Clinical Research Coordinator III within the Office of Human Research Services (OHRS) at the Rutgers Cancer Institute.

The primary purpose of the Oncology Clinical Research Coordinator III position is to assist Rutgers Cancer Institute's multidisciplinary Disease Specific Group (DSG) Clinical Research Teams with conducting clinical trials. This role is responsible for assisting the clinical research team in overall study coordination, including but not limited to, preparing for study initiation and activation, acquisition of source documents, record maintenance, preparing study documents, patient registration, coordinating and data entry.

The Oncology Clinical Research Coordinator III serves as a study liaison with study sponsors and provides assistance with overall study coordination that is in compliance with the Food and Drug Administration (FDA), National Institutes of Health (NIH), Code of Federal Regulations (CFR), Good Clinical Practice (GCP) guidelines, Office for Human Research Protection (OHRP), Health Insurance Portability and Accountability Act (HIPAA), institutional guidelines and standard operating procedures (SOPs) set forth by Cancer Institute of New Jersey and RBHS.

Additionally, the Oncology Clinical Research Coordinator III understands and meets/exceeds the needs of all customers (patients, families, study sponsors, monitors, auditors, multidisciplinary team, etc).

Essential Duties and Responsibilities include the following:

• Works with the Protocol Activation Office to coordinate the initiation and activation of all new clinical trial protocols assigned. This includes, but is not limited to, verifying Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), data collection plans and finance/contract approvals prior to study activation. Coordinates the preparation of study tools including but not limited to study binders, medication diaries, eligibility checklists and flow sheets (as required).
• Using OnCore®/Excel®/Word®, develops study tools, including but not limited to eligibility checklists, medication diaries, calendars, and flow sheets (as required).
• In collaboration with the Research Nurse Clinician (RNC) and/or physician, reviews patient's charts and medical history to confirm protocol eligibility and obtains source documents (i.e., medical record documentation) as needed. Under the direction of the RNC and/or physician, ensures that IRB approved informed consent has been obtained, signed, placed in the medical record, and that a copy was provided to the patient.
• Registers consented research patients with study sponsor (e.g., industry, NCI Cooperative group, etc.) and inputs into the OnCore® clinical trials database maintained by the Cancer Institute of New Jersey.
• Coordinates the clinical assessments and patient care of study participants, including but not limited to, screening and evaluation of study participants with ancillary departments (such as pathology, radiology, clinical laboratory, surgery, infusion services) within the Cancer Institute as per protocol requirements.
• Maintains research record (e.g., patient consent, eligibility, registration confirmation, corresponding source documents, etc.) for all patients enrolled in Cancer Institute of New Jersey clinical trials across the health system.
• In collaboration with the RNC and physician, assists with grading adverse events using the most recent version of National Cancer Institute (NCI) common toxicity criteria or protocol specific grading scales. Completes Serious/Unexpected Adverse Event (SAE) form for all internal and multicenter serious/unexpected adverse events as required by study sponsors, federal requirements and institutional guidelines.
• Ensures research record (e.g. patient consent, eligibility, CRFs, registration confirmation, corresponding source documents, etc.) is maintained for all patients enrolled in Cancer Institute of New Jersey clinical trials across the health system.
• Enters data as directed by data capture plan (DCP) into various auditable databases or electronic data capture systems and/or oversees data entry and validation to ensure accuracy of data. Supports data management process by addressing queries from monitors.
• Collaborates with BRS and/or OHRS research staff members, to ensure procurement of protocol specific bio-specimens (e.g. blood, urine and tissue) are collected and processed according to protocol specific guidelines.
• Performs other related duties as assigned.

Minimum Education and Experience:

• Bachelor's Degree in a relevant science or a related field (e.g. public health, healthcare administration).
• A minimum of one to three (1-3) years of research related experience.
• Applicants may substitute additional related experience such as laboratory, clinical or medical experience for the education requirements on a year-for-year basis.

Physical Demands and Work Environment:

PHYSICAL DEMANDS:

• Walking, sitting, standing, pushing, pulling, bending and lifting.
• No special vision requirements.
• Lifting up to 25 lbs. Possible travel for Investigator meetings.
• Possible travel to retrieve data from other clinics.

WORK ENVIROMENT:

• Moderate noise (examples: business office with computers and printers, light traffic).
• Exposure to blood, urine, sputum, excrement, anti-neoplastic agents and possible exposure to infectious and communicable diseases that requires use of personal protective equipment.