full-time position with Neurosurgery; 40 hours per week; Monday - Friday
Under the direct supervision of the Clinical Trials Manager or Principal Investigator, will be responsible for monitoring clinical course and collection of research data on patients entered onto research protocols in the Neurosurgery Pain Institute Clinical Trials Group and possibly, external institutions. Responsible for organization, entry, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner. These data will be used to generate specific study findings after the data is analyzed.
Maintain good working knowledge of all assigned protocols and reporting requirements. Transmit and distribute protocol information. With assistance, prepare and submit annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements. Adhere to all protocol requirements to ensure the validity of the clinical research data. May assist principal investigator and/or program manager in defining information and plans required to accomplish goals of studies. May help design and create protocol specific data collection forms with assistance. Verify patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements. Confirm patient registrations and relevant data points in institutional and sponsor databases. Maintain a research chart for each patient. Collect, enter and compile clinical data from a variety of sources. Ensure accuracy and timeliness of data so that information may be used by the physician in treatment planning for individual patients, presentations and publication. Verify scheduling of patient appointments, tests, and follow up visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements. May design and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests. Meet regularly with Principal Investigator, Research Nurse, and Research Program Manager to review data accuracy and overall study progress. Participate in all mandatory meetings to develop increasing knowledge of assigned clinical trial and registry requirements. Maintain a protocol database or spreadsheet for tracking patient activity and data submission to internal and/or external registries. Prepare reports on individual patients or the study as required by the principal investigators and/or external agencies. Enter patient demographic and clinical data into institutional database as required. Respond in timely manner to special projects or queries related to the data. Prepare for and participate in monitoring and audit of studies. Correct errors in database when necessary. Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information. Understand importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general. Regular contact with physicians, other health care personnel and, occasionally, patients.
Perform other duties as required.
Bachelor's degree in related discipline. Some related experience. Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Proficiency in PC operations and software application such as MS Windows, Excel, Word, and Access. Ability to learn new database and software applications. Excellent organizational skills and attention to detail. Able to follow multiple, detailed directions of various protocols. Excellent time management skills and oral and written communication skills. Able to use good judgment, tact and sensitivity.
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130... years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Baltimore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.