Classified Title: Research Program Coordinator Role/Level/Range: ACRO/03/CD Salary: $16.10 - $22.12 Status: Full-Time Work Schedule/Hours: M-F/8:30-5:00 Department name: 10002915-SOM Onc Oncology Location: 33-MD:Johns Hopkins Bayview Personnel area: School of Medicine
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. This position will focus on non-drug interventional studies such as (but not limited to) palliative care studies, care delivery studies, and health outcomes studies in the division of thoracic oncology.
Specific Duties and Responsibilities:
Maintains detailed working knowledge of all assigned protocols. Transmits and distributeprotocol information. Responsible for submission, verification, and maintenance of protocol specific information on the Web Protocol Library.
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.
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.
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.
Assists in the consent process for patients.
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.
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.
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.
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.
In conjunction with clinical personnel writes and prepares adverse event reports on patients enrolled on studies, and submits these to the appropriate agencies.
Submits continuing reviews, protocol events, safety reports, and protocol amendments to the JHMIRB through eIRB electronic review system.
Prepares for and participates in audits of studies. Corrects errors in data when necessary.
Knowledgeable of and complies with Good Clinical Practice, ICH Guidelines and SKCC Clinical Research Office policies.
May assist in collection of data to be entered in to database.
Bachelor's degree in 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.
Coursework in the sciences/health care and experience with Oncology and eIRB is desirable.
The successful candidate(s) for this position will be subject to a pre-employment background check.
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The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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