Research - Laboratory/Non-Laboratory, Staff/Administrative
Under the direct supervision of the Principal Investigator, the Research Program Coordinator is responsible recruitment and consenting of patients. The Research Program Coordinator is responsible for processing of all patient clinical research specimens as well as conducting participant follow up in a timely manner.
DUTIES AND RESPONSIBILITIES
Recruitment & enrollment: Ensures initial & ongoing eligibility of all subjects for assigned research studies:
Screens potential research subjects for participation in research studies or clinical trials (including: Review of medical history, concomitant meds, pathology, other relevant documents)
Abstracts data from a variety of sources to complete pre-study work-up
Demonstrates understanding of the informed consent process
With guidance & as appropriate, obtains informed consent from research subjects
As appropriate, documents obtaining of informed consent in study records
In conjunction with PI, monitors protocol enrollment goals
In collaboration with healthcare team, evaluates potential subjects for research participation
Oversees the collection of study data in the form of questionnaires (online and paper) and conducts initial quality checks. Assists with management.
Responsible for independently coordinating blood and tissue banking protocols to ensure proper collection and handling of samples.
Responsible for collection and handling, and transporting of patient samples to ensure quality samples.
Responsible for ordering archival tissue from internal and external sources.
Maintain current documentation on all research study procedures.
Serves as department liaison with outside support groups, i.e. pathology, gastroenterology, and multiple research laboratories both in-house and third-party. Ability to anticipate daily changes in schedule, maintaining a smooth patient flow.
Uses universal safety precautions to protect self and co-workers from biohazardous materials, including blood-borne pathogens.
Maintains good working knowledge of all assigned research 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 research data for each assigned protocol. With assistance, prepares and submits annual renewal requests, amendments and adverse event reports with clinical input according to IRB 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 study requirements.
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 for presentations and publication.
Verifies scheduling of patient appointments and tests.
Meets regularly with Principal Investigator, Co-investigators and Research Program Manager to review data accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of assigned requirements.
Equipment, Machine, or Tool Requirements:
General computer skills, with experience with Microsoft Office
Required: Bachelor's Degree related discipline.
Related experience may substitute for required education as per the JHU Equivalency Formula.
Eligibility for certification by a professional clinical research organization is preferred.
Experience in database operations required.
Some related experience required.
Additional graduate level courses may substitute for some work experience.
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
Classified Title: Research Program Coordinator Working Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.26 - $22.35 Employee group: Full Time Schedule: M-F 8:30am- 5pm Exempt Status: Non-Exempt Location: 04-MD:School of Medicine Campus Department name: 10002940-Cancer Immunology/GI Clinical Research Personnel area: 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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