The Department of Oncology is seeking a Research Program Coordinator to work under the direct supervision of the Clinical Research Program Manager, the Research Program Coordinator is responsible for monitoring the clinical course and collection of research data on patients entered onto protocols at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (SKCCC). The Research Program Coordinator is responsible for the organization, submission, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner.
Specific Duties and Responsibilities:
1. Maintains detailed working knowledge of all assigned protocols. Transmits and distributes protocol information. Responsible for submission, verification, and maintenance of protocol specific information on the Web Protocol Library.
2. Maintains electronic or hard copy regulatory binder for each assigned protocol. Adheres to all protocol requirements to ensure the validity of clinical research patient data. With minimal assistance, prepares annual renewal requests and submission of protocol amendments and other regulatory duties as required.
3. May assist the principal investigator in defining information and plans required to accomplish goals of studies. May help design and create study specific data collection forms.
4. Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements. Confirms patient registrations and relevant data points in SKCCC electronic patient databases.
5. Maintains a research chart for each patient. Collects and compiles clinical data from a variety of sources. Enters and updates the Clinical Research Management System (CRMS) database promptly. Insures accuracy and timeliness of data so that information may be used by the physician in planning treatment for individual patients.
6. Verifies scheduling of patient appointments, tests, and follow-up visits at the appropriate time in the treatment cycle to assure completion of protocol requirements. May design and compile materials which aid physicians / other staff in complying with protocol requirements for these visits and tests.
7. Meets regularly with principal investigators and supervisor of studies to review data accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of clinical trials. Completes minimum requirements for additional educational units.
8. Prepares reports on individual patients or the study as required by the principal investigator and/or external agencies. Responds to special projects or queries related to data.
9. In conjunction with clinical personnel writes and prepares adverse event reports on patients enrolled on studies, and submits these to the appropriate agencies.
10. Submits continuing reviews, protocol events, safety reports, and protocol amendments to the JHMIRB through eIRB electronic review system.
11. Prepares for and participates in audits of studies. Corrects errors in data when necessary.
12. Is knowledgeable of and complies with Good Clinical Practice, ICH Guidelines and SKCCC Clinical Research Office policies.
Bachelor's in a related discipline and 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.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
Classified Title: Research Program Coordinator Role/Level/Range: ACRO/03/CD Salary: $16.09 - $22.12 Status: Full-Time Work Schedule/Hours: M-F, 8:30 am - 5:00 pm Department name: 10002915-SOM Onc Oncology Location: 04-MD:School of Medicine Campus Personnel area: School of Medicine
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