The Voice of Business

  • Clinical Research Coordinator

    Decatur Memorial Hospital
    Job Description
    Department: 72320 Clinical Research
    Status: Full Time 40 HRS
    Shift: Days
    Work Hours: Mon - Fri 8:00-4:30
    Job Details:
    • Summary
      Manages Research Study Activities.

      Essential Functions and Job Duties
      • Coordinates screening and enrollment of clinical trial patients.
      o Ensures eligibility requirements are met and reviews with investigator.
      o Assists investigator in explaining and educating patient and family on protocol and informed consent.
      o Obtains informed consent from potential study candidates and / or families.
      o Continues informed consent process with study patients through duration of participation
      o Obtains re-consent in a timely manner
      o Manages patient enrollment via guidelines established by study protocol.
      o Ensures protocol required testing is ordered and completed as outlined in the study protocol.
      o Coordinates study-setup
      o Screens EMR routinely for potential study patients
      o Maintains screening records and patient accruals in CREDIT database

      • Performs data management activities for clinical trials
      o Gathers and verifies source documents.
      o Abstracts and submits accurate data as requested.
      o Verifies the accuracy, completeness and timely submission of case report forms.
      o Corrects and resubmits data or answers queries within a timely manner per the study sponsors guidelines.
      o Utilizes computer software to collate and report abstracted data elements.
      o Maintains a record keeping system that documents patients/participants registered on research studies, their protocol status, copies of the informed consent, and the data submitted.
      o Review patient records for identification of potential adverse events or protocol deviations.
      o Redacts all patient documents and imaging data prior to submission to research bases
      o Reviews and prepares charts for audits
      o Serves as a liaison to research base auditors and pharma monitors
      • Maintains investigational drug (IND) inventory
      o Reviews protocols and assesses current inventory of IND.
      o Orders INDs from Pharmaceutical Management Branch at National Cancer Institute or trial sponsor.
      o Maintains inventory on individual drug accountability records.
      o Ensures treatment order is correct by reviewing protocol guidelines and calculating dose prescribed.
      o Assesses each IND for expiration dates and follows protocol and department guidelines for drug destruction.
      • Order and track laboratory kits needed for research related blood draws.  Process and ship specimens as required by protocol.  Maintain hazardous materials education certification. 
      • Demonstrates clinical competency by providing direct patient care as required by protocol (EKGs, vitals, lab draws).  Obtains protocol specific training as required to enroll patients on clinical trials. 
      • Performs protocol reviews prior to implementation and stays current on protocol amendments
      • Serves as a professional resource regarding clinical trials, protocol procedures and protocol compliance for investigators, nurses, pharmacists, pathologist, radiologists and other health care personnel. 
      • Trains new study coordinators on job duties/functions and assesses competence
      • Attends cancer conference to provide information about current protocol availability for presented cases.
      • Attends NCI research base meetings for updates on clinical trials
      • Attends Investigator Meetings.
      • Attends educational workshops and / or conferences as time allows when requested.
      • Participates in activities such as continuing education, community work, and quality improvement to promote professional development. 
      • Demonstrates a knowledge and compliance with GCP guidelines in the conduction of clinical research.
      • Performs other duties as assigned.
      A bachelors degree in nursing or other health-related field is preferred.  Pertinent LPN or RN licensure/registration must be maintained if applicable.  Previous research experience and/or recent nursing experience is preferred.