Classified Title: Research Program Coordinator Role/Level/Range: ACRO/3/CD Salary: $16.09 - $$22.12 Status: Full-Time Work Schedule/Hours: M-F 8:30 am- 5 pm Department name: 10002927-Cancer Immunology Lab Research Location: 04-MD:School of Medicine Campus Personnel area: School of Medicine
The Department of Oncology is seeking a Research Program Coordinator that will be responsible for conducting tasks related to study recruitment and specimen collection for the Microbiome Program. The Microbiome Program works with diverse groups, particularly within the Sidney Kimmel Comprehensive Cancer Center, to conduct studies to determine if the gut microbiome and body site-specific microbiomes influence disease and its therapies. The research program assistant will be the key person who interacts with physician investigators, clinic nurses, administrative schedulers and study participants to facilitate the collection of data forms and human research specimens according to the IRB protocol.
In general, under the supervision of the PI, Microbiome Research Program Manager and with the permission of the patient's physician, checks clinic schedules and either at a scheduled visit and/or ahead of a scheduled appointment may contact potential participants by telephone to inform them about the microbiome study. In some cases, a brief screening interview to determine if the individual meets study criteria may need to be done. Provides or mails study materials to interested subjects and enters recruitment information into clinical research database. In some instances, on the day of clinic visit, answers questions about the microbiome study, obtains informed consent and facilitates collection of demographic survey information from research subjects. Acts in concert with study physician and nurses to collect research samples from participants as described in the IRB protocol including stool, urine, blood, mouth swish, colon biopsies among others. Conducts follow up phone calls as needed to study participants. Manages study forms and maintains confidentiality of patient information. Advises research team at Johns Hopkins in advance of specimen collection and coordinates sample delivery to laboratory personnel.
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.
Specific Duties and Responsibilities:
1. 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.
2. 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.
3. 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.
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 Program Manager or Principal Investigator in presentations, reports 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 Program Manager/Principal Investigator/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 protocol requirements.
8. Maintains a protocol database or spreadsheet for tracking patient activity and data submission to internal and/or external registries.
9. 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.
11. 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..
12. Ability to think critically and to solve problems that arise related to study protocols.
13. Ability to be flexible in work conditions and function well in a team setting.
14. Has capacity to travel between study sites within or near Baltimore City. Study sites may include the Johns Hopkins East Baltimore campus, Whitemarsh, Green Spring Station or others.
BA/BS degree required in related discipline and some related experience required. 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.
Experience in database operations preferred.
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at email@example.com. For TTY users, call via Maryland Relay or dial 711.
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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