Assists with research studies in the Division of Surgical oncology at Johns Hopkins School of Medicine. Assists in project planning, and ensures that pre-established work scope, IRB-approved study protocol, and regulatory requirements are followed. Recruits and coordinates research subjects, as appropriate. Develops and maintains recordkeeping systems and procedures.
Under the direct supervision of the Research Program Manager and/or Principal Investigator(s), the Research Program assistance is responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols at the division.
The Research Program assistant is responsible for the organization, entry, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner, in addition to performing basic laboratory techniques in processing of human tissue/blood sample, cell culture, molecular biology procedures, ordering, and equipment trouble-shooting. This data will be used to generate specific study findings after the data is analyzed. This is an introductory level position in managing clinical trials and/or registry databases.
Recruits, instructs, and coordinates research subjects and/or volunteers, as appropriate to specific study objectives and work scope.
Implements and maintains data collection and analysis systems in support of research protocol; including the management of data, paper files, and electronic databases.
Ensures the smooth and efficient day-to-day operation of research and data collection activities in compliance with The Health Insurance Portability and Accountability Act (HIPAA) and other relevant patient privacy statutes.
Coordinates the day-to-day activities in the carrying out of research protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives.
Develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators and/or regulatory bodies.
Performs miscellaneous job-related duties as assigned.
Acts as the primary administrative point of contact for internal research staff
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 Research Protocol Library, as appropriate.
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 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 and schedules 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.
Performs structured patient tests in the clinic, observe behaviors and anomalies, and take patient medical and surgical histories.
Document stages and changes of medication or condition during course of study and notify appropriate providers.
Assists clinical staff in the collection of samples and has detailed knowledge of sample requirements.
Transports, processes, and ships study blood and tissue samples, as assigned.
Operates basic laboratory equipment; complies with biohazard safety standards through proper handling of hazardous chemical and biological agents; uses sterile techniques to avoid contamination; uses universal safety precautions to protect self and co-workers from biohazardous materials; monitors inventory of supplies required for studies.
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 Clinical Research Office policies.
Bachelor's degree in biology, chemistry or related field.
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.
JHU Equivalency Formula: 18 graduate degree credits (semester hours) 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.
At least one year working in a Breast cancer research setting preferred.
Scientific writing, generating figures and tables from data, and reading and summarizing research literature.
Special Knowledge, Skills, and Abilities:
Highly detailed-oriented with excellent organizational and time-management skills.
Excellent oral and written communication skills.
Excellent work attitude and habits including reliability, flexibility, and the ability to think and work independently and as a team.
Ability to follow multiple, detailed directions of various protocols.
Must have excellent oral and written communication skills.
Experience in database operations required, and related work experience in coordination of medical or laboratory research required.
Proficiency in PC operations and software application.
Classified title: Research Program Coordinator
Working title: Research Program Coordinator
Role/Level/Range: ACRO 35/E/03/CD
Starting Salary Range: $16.26 – $22.35 (commensurate with experience)
Employee group: Part-Time
Employee Status: Non-Exempt
Schedule: Monday-Friday - 8:30am-5:00pm 27hrs/Wk
Location: Bayview - 4940 Eastern Avenue, Baltimore, MD – Johns Hopkins Bayview Medical Center
Department name: 10003178-SOM Sur Bay Gen Surgery BMC
Personnel area (School): SOM – School of Medicine
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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