Clinical research coordinator (oncology)

Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. We are seeking a Clinical Research Coordinator who will administratively coordinate clinical protocol implementation, typically for a single study. Will ensure efficient logistical implementation of the study activities and provide administrative support for research-related regulatory issues. Under the direct supervision of the Sr. Research Program Supervisor or Nurse Manager, the Clinical Research Coordinator is responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols in the Department of Hematologic Malignancies. The Clinical Research Coordinator is responsible for the organization, entry, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner. This data will be used to generate specific study findings after the data is analyzed.

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 meetings.
• Maintains good working knowledge of all assigned protocols and reporting requirements.
• Transmits and distributes protocol information.
• Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library and the Clinical Research Management System.
• 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.
• Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
• Confirms patient registrations and relevant data points in databases for the SKCCC Clinical Research Office and Oncology Information Systems.
• Contribute to the development of recruitment strategies 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 the 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 setup of the 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 the 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.
• Completes minimum requirement for continuing educational units. Has working knowledge of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies.
• Other duties as assigned.

In addition to the duties above, maintains good working knowledge of all assigned protocols and reporting requirements. Transmits and distributes protocol information. Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library and the Clinical Research Management System. Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements. Confirms patient registrations and relevant data points in databases for the SKCCC Clinical Research Office and Oncology Information Systems. Completes minimum requirement for continuing educational units. Has working knowledge of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies.

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.