Clinical Research Coordinator IV - Oncology

What You'll Help With

Transform Healthcare by managing administrative activities associated with the conduct of research studies, ensuring compliance with guidelines set by governing agencies and institutional policy. Serve as a liaison between research sponsors, site management organizations, local Institutional Review Board (IRB), physicians/staff, and R&D.

• Recruit, screen, and enroll eligible study participants.
• Obtain informed consent from study participants.
• Manage completion and submission of study related documentation.
• Communicate with research sponsor or CRO, local or central IRB, Research and Development, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance.
• Monitor enrollment goals and implement action plans, as needed.
• Care for tasks such as developing informed consents and screening materials, scheduling visits, and acting as a liaison between research participants and the research study team.
• Collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources.
• Collect, process, and ship research specimens as directed in the protocol.
• Ensure compliance with study protocol and requirements of regulatory agencies.
• Track and report adverse events and protocol deviations.
• Coordinate all site related monitoring or auditing visits from sponsor or federal agency during the course of the study and at closure.
• Prepare, submit, and maintain IRB, R&D, FDA and/or any other funding or regulatory documents and research correspondence.
• Develop and maintain patient databases and study maintenance logs including but not limited to training logs, delegation of responsibility logs, screening logs, enrollment logs, and investigational product log.
• Provide in-depth clinical research training and mentorship to junior and intermediate CRCs.
• Contribute to trial planning, development, and implementation activities.
• Support the research process for all members of the research team and ancillary departments involved in research.
• Aid in protocol feasibility determination, identifying potential barriers, and proactively solving problems.
• Assist in developing data collection systems and compiling study-related reports.
• Aid in writing research grant proposals, manuscripts, study materials, brochures, and correspondence.
• Act as a champion for clinical research at Carilion Clinic.

  Qualifications

  • Education: Bachelor's degree in science or related field required. Master's degree in science or related field preferred.
  • Experience: Minimum of ten (10) years of Clinical Research (or equivalent research experience) AND a master's degree in science OR Minimum of fifteen (15) years of Clinical Research (or equivalent research experience) AND a bachelor's degree in science required.
  • Licensure, certification, and/or registration: Nationally recognized clinical research certification from Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) required upon hire.
  • I.A.T.A. (International Air Transport Association) certification is required for projects that will be transporting specimens prior to completion of IRB application.
  • Other Minimum Qualifications: Excellent computer skills; strong knowledge of word processing, spreadsheets, databases, and internet environment. Knowledge of medical and/or pharmaceutical terminology strongly desired. Strong organization and communication skills required. Able to work with multiple interruptions and to perform multiple tasks at any given time. Must have strong leadership, interpersonal and teamwork skills.

    Compensation

    $63,377.60 - $95,076.80 Employee pay is based on a variety of factors, including qualifications, credentials, education, and prior work experience. The compensation range does not include benefits or pension plan. For more information, contact the HR Service Center at 1-800-599-2537.