Oncology Clincl Research Nurse

Oncology Clinical Research Nurse

Job

Location:

Augusta University

Full/Part Time:
Full Time

Regular/Temporary:

This position provides research coordination for assigned oncology studies. Responsibilities include becoming familiar with study protocols, reviewing charts and screening potential study participants, conducting study procedures that may include blood draws and preparing specimens for shipment and testing, reading lab results, collecting and entering study data and preparing and maintaining documents.

• Evaluation & Implementation of Clinical Trials
  • Review study protocols, primary disease category and investigational drug information; familiar with all study requirements; communicate and make arrangements with the different areas of AU involved in the study (imaging radiology, laboratory services, pathology, patient scheduling, etc.); set up studies according to sponsor requirements and IRB policies; adapt study for changes due to amendments and extensions.
• Recruitments of Subjects
  • Familiarity with inclusion/exclusion criteria; prepare recruitment plan with Principal Investigators; prepare advertisements for institutional approval; prepare correspondence to potential sources for patient accrual; liaison between sources of referral (clinical staff, community groups, referring physicians) and Principal Investigator; screen patients for inclusion/exclusion criteria; verify informed consent procedures.
• Conduct of Study
  • Schedule patient visits, laboratory tests and procedures; under the direction of the Principal Investigator, dispense investigational drugs per protocol and AU requirements; obtain laboratory samples; obtain vital signs, perform ECGs when required and assist physician with physical examinations; conduct Good Clinical Practices.
• Medical Management
  • Assess patient's general health; accurately report all adverse events within required time frame to sponsor and IRB; notify Principal Investigator of patient's condition; provide assistance to Principal Investigators for management of adverse events; schedule follow-up procedures for resolution of adverse events.
• Study Documentation & CRF Completion
  • Help maintain all FDA and sponsor required regulatory documents; ensure documentation and reporting of required procedures/tests and study information; accurately complete source documents; work with data coordinators to accurately complete case report forms and data entry; enter patient information into OnCore.
• Reports & Financial Documentation
  • Complete all reports, including the annual study continuation report required by IRB; prepare forms and submit Investigational New Drug (IND) Safety Reports to the IRB.
• Other Duties
  • Perform other related duties/tasks as needed.

Required Qualifications

Educational Requirements

Bachelor's degree in nursing from an accredited college or university and licensed to practice as a Registered Nurse in the state of Georgia with a minimum of two years of clinical experience in a specialized area;
Current American Heart Association Healthcare Provider BLS/BCLS certification.

OR

Associate's degree in nursing from an accredited college or university and licensed to practice as a Registered Nurse in the state of Georgia with a minimum of six years of clinical experience in a specialized area;
Current American Heart Association Healthcare Provider BLS/BCLS certification.

Preferred Qualifications

Bachelor's degree from an accredited college or university in a health-related field or life sciences with ten years' experience in oncology or clinical research; CCRC certification or eligibility;
Oncology Nurse Certification;
Knowledge of federally funded projects, industry-sponsored projects and investigator-initiated studies.

Knowledge,…