We are seeking a Research Program Coordinator who will work under the direct supervision of the Program Manager and will be responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols at the Sidney Kimmel Comprehensive Cancer Center and possibly, external institutions. The Research Program Coordinator is responsible for the 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. This individual will be responsible for obtaining archival tissue for clinical trials. The Research Program Coordinator will be attend biopsies for clinical trials.
Specific Duties & Responsibilities
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.
Maintains regulatory binder for each assigned protocol.
With assistance, prepares and submits annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements.
Adheres to all protocol requirements to ensure the validity of the clinical research data.
May assist the 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.
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.
Maintains a research chart for each patient.
Collects, enters and compiles clinical data from a variety of sources.
Ensures accuracy and timeliness of data so that information may be used by the physician in treatment planning for individual patients, presentations and publication.
Verifies 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.
Meets regularly with Principal Investigator, Research Nurse, and Research Program Manager to review data accuracy and overall study progress.
Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements.
Maintains a protocol database or spreadsheet for tracking patient activity and data submission to internal and/or external registries.
Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies.
Enters patient demographic and clinical data into institutional database as required.
Responds in a timely manner to special projects or queries related to the data.
Prepares for and participates in monitoring and audits of studies. Corrects errors in database when necessary.
Completes minimum requirement for continuing educational units. Has working knowledge of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical.
Research Office Duties
Collect archival tissue samples from the different institutions and maintain a record of samples. Reviews Vaccine calendar for biopsy schedule times and notifying nurse of corrections. Ensures that biopsy samples are collected in the correct medium and taken to the correct labs for processing. This will be maintained until the Biopsy Management Service is fully operational.
Collect archival tissue samples from the different institutions and maintain a record of samples.
Reviews Vaccine calendar for biopsy schedule times and notifying nurse of corrections. Ensures that biopsy samples are collected in the correct medium and taken to the correct labs for processing. This will be maintained until the Biopsy Management Service is fully operational.
May occasionally serve as back up during critical staffing shortages.
Bachelor's Degree in related discipline.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Related work experience preferred.
Classified Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.75-$23.00-$29.30 HRLY (Commensurate with experience) Employee group: Full Time Schedule: M-F 8:30am- 5:00pm Exempt Status: Non-Exempt Location: Hybrid/School of Medicine Campus Department name: SOM Onc Cancer Immunology/GI Clinical Re Personnel area: School of Medicine
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:
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.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
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