Under the direct supervision of the Clinical Research Program Manager or the Principal Investigator, the Sr. Research Program Coordinator is 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 participating sites. The Sr. Research Program Coordinator is responsible for the organization, entry, maintenance and accuracy of all clinical research data for complex and detailed clinical trials, and may assist with orientation of less senior research staff in protocol and clinical research information. This is an intermediate level position in managing clinical trials and/or registry databases within the research program.
Specific Duties and Responsibilities:
1. Maintains good working knowledge of all assigned protocols and reporting requirements. Works on complex clinical studies which require a high level of knowledge, coordination, and data abstraction. Transmits and distributes protocol information. Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library.
2. Maintains regulatory binder for each assigned protocol. 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.
3. May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies. Will design and create protocol‑ specific case report forms as needed. May also assist less experienced staff in design and creation of such 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 databases for the SKCCC Clinical Research Office and Oncology Information Systems.
5. 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, presentations, and publication.
6. 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.
7. 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.
8. Will develop and maintain a protocol database or spreadsheet for tracking patient activity, financial management and data analysis as needed.
9. Will meet with clinical trial financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract. May participate in the development of invoicing schedules.
10. 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.
10. Prepares for and participates in monitoring and audits of studies. Corrects errors in database when necessary. Writes responses to audit reports with input from the Principal Investigator.
11. Completes minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies. May instruct introductory level clinical research personnel in these guidelines and policies.
BA/BS degree in Biological/Social Sciences or other appropriate discipline and a minimum of three years of experience in complex and detailed clinical trails and medical research required. Proficiency in the use of software applications, databases, spreadsheets, and word processing is also required. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience.
Additional graduate level course work or certification as a Clinical Research Professional is desired.
Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information. Understands the 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, requires the use of good judgment, tact and sensitivity.
This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s). It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.
Classified Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Salary: $38,536 - $52,989 Status: Full-Time
Department name: 10002915-SOM Onc Oncology Work Schedule: M-F/8:30am-5:00pm Location: 04-MD:School of Medicine Campus Personnel area: School of Medicine
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