Under the direct supervision of the Sr. Clinical Research Program Manager and the Principal Investigator(s), 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. This is an introductory level position in managing clinical trials and/or registry databases within the Developmental Therapeutics Program.
Specific 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.
BA/BS degree with course work in sciences/health care required, and some experience. Additional experience may substitute for some education, to the extent permitted by the JHU equivalency formula.
Experience in database operations required, and related work experience in coordination of medical or laboratory research required. 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
Knowledge of medical terminology highly desired
Ability to manage multiple and competing priorities
Must have excellent time management skills
Must have excellent oral and written communication skills
JHU Equivalency Statement: 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.
Role/Level/Range: ACRO/03/CD Starting Salary Range: $16.26 - $22.35/Hourly Employee Group: Full Time Schedule: Monday - Friday, 8:30 a.m. - 5:00 p.m./40 Hours per Week Exempt Status: Non-Exempt Location: School of Medicine - East Baltimore Campus Department Name: Oncology Personnel Area: School of Medicine
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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