Department: Oncology - GI Cancer Work Schedule/Days: 27 hours/week
Under the direct supervision of the Program Manager or the Principal Investigator, the 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 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.
Duties and 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 policies.
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.
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.
Special Knowledge, Skills, or Abilities / Competencies: *Proficiency in PC operations and software application such as MS Windows, Excel, Word, and Access. *Ability to learn new database and software applications is required. *Excellent organizational skills required. *Excellent attention to detail skills required *Ability to follow multiple, detailed directions of various protocols *Knowledge of medical terminology highly desired *Must have excellent time management skills *Must have excellent oral and written communication skills
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.
Eligibility for certification by a professional research organization is preferred.
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.