• Clinical Research Coordinator (Oncology) - #Staff

    Johns Hopkins University (Baltimore, MD)


    The Coordinating Center Clinical Research Coordinator is responsible for dispersing, collecting, and monitoring research information on multi-site investigator-initiated studies being managed by the Sidney Kimmel Comprehensive Cancer Center (SKCCC) Coordinating Center. The Coordinator is responsible for maintaining compliance of the assigned research studies, including coordinating study activation related documents and submissions to pertinent regulatory agencies, assisting database design, approval, and implementation, amendment management, subject eligibility review, and monitoring regulatory and subject compliance for external sites. This is the entry-level position with the SKCCC Coordinating Center. Candidate will report to the Coordinating Center Clinical Research Manager and work closely with the Principal Investigators.

    Specific Duties & Responsibilities

    + Coordinate all activities of a clinical research study to ensure adherence to protocol and validity of findings.

    + Participate in clinical study start-up meeting.

    + Assist research nurses, study coordinators, principal investigators, and other study personnel in executing protocol related activities.

    + Explain the study background and rationale for the research to potential and current participants

    + Contribute to development of recruitment strategy for participants for assigned study.

    + Implement a variety of techniques for recruitment as appropriate, e.g., print and web-based advertisements, contact referring physicians, participate in community events, etc.

    + Independently conduct consenting process or ensure consent is obtained on appropriate participants.

    + Schedule participants for required activities and provide any special instructions prior to upcoming tests/exams.

    + Serve as liaison to study participants.

    + Assist with set up of data collection system and enter and organize data.

    + Assist in coordinating study meetings.

    + Participate in study meetings and provide updates on protocol implementation status and make recommendations on operational issues.

    + Assist with preparation of submissions to the Institutional Review Board (IRB)

    + Liaison with IRB on administrative matters and facilitate communications with the PI.

    + Conduct literature searches to provide background information.

    + Obtain and maintain excellent operating knowledge of assigned clinical protocol, clinical equipment, and clinical computer systems.

    + Oversee budget expenditures for study operations.

    + Other duties as assigned.

    In addition to the duties described above:

    + Works closely with PI, study biostatistician, Coordinating Center Clinical Research Manager, and other Clinical Research Office (CRO) members to develop electronic case report forms (i.e.REDCap) and study calendars

    + Review study documents, prepare for JHM IRB submissions and other regulatory agencies such as NCI, FDA, and ClinicalTrials.gov.

    + Ensure that coordinating center standards for performance of clinical trials at multiple sites are adhered to, as well as, ensuring system for generation, tracking, and resolution of data queries is adhered to.

    + Prepare reports for audit and monitoring results. Notify appropriate authorities of major violations.

    + Comply with ICH Good Clinical Practice, IRB, and NCI Coordinating Center policies and procedures. Will instruct and train research personnel assigned to multi-center trials in these guidelines and practices

    Minimum Qualifications

    + Bachelor's degree in a related field.

    + Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

    Preferred Qualifications

    + Phlebotomy certified to assist with clinical responsibilities.

     

    Classified Title: Clinical Research Coordinator

     

    Job Posting Title (Working Title): Clinical Research Coordinator (Oncology)

    Role/Level/Range: ACRO40/E/03/CD

    Starting Salary Range: $17.20 - $30.30 HRLY ($19-$22hour targeted; Commensurate w/exp.)

     

    Employee group: Full Time

     

    Schedule: Mon-Fri

     

    FLSA Status: Non-Exempt

     

    Department name: SOM Onc Clinical Research Office

     

    Personnel area: School of Medicine

     

    Equal Opportunity Employer

     

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.