Johns Hopkins University Research Program Assistant in Washington, District Of Columbia
The Department of Urology is seeking a Research Program Assistant who will assist with research studies and with project planning as well as ensures that pre-established work scope, IRB-approved study protocol, and regulatory requirements are followed. The Research Program Assistant recruits and coordinates research subjects, as appropriate and develops and maintains recordkeeping systems and procedures. This individual also assists with writing protocols and results.
Under the direct supervision of the Principal Investigator(s), the Research Program Assistant will monitor the clinical course and collection of research data on patients entered onto research protocols at the division. This role is responsible for the organization, entry, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner. This data will be used to generate specific study findings after the data is analyzed. This position will perform basic laboratory techniques in processing of human tissue/blood sample, cell culture, molecular biology procedures, ordering, and equipment trouble-shooting. This is an introductory level position in managing clinical trials and/or registry databases.
Specific Duties & Responsibilities :
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.
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 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 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.
Performs miscellaneous job-related duties as assigned.
Minimum Qualifications (Mandatory) :
High School Diploma/GED.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications :
Some college courses.
Some related work experience in coordination of medical or laboratory research.
Experience in database operations.
Scientific writing, generating figures and tables from data, and reading and summarizing research literature.
Special Knowledge, Skills & 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.
Excellent oral and written communication skills.
Proficiency in PC operations and software application.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. 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.
Classified Title: Research Program Assistant
Starting Salary Range: $15.00 - $18.50/hr (commensurate with experience)
Employee group: Full Time
Schedule: M-F-40 hours
Exempt Status: Non-Exempt
Location: District of Columbia - Sibley
Department name: SOM Uro Urology Research
Personnel area: Johns Hopkins University
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.
Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons or because the individual is pregnant or attempting to become pregnant. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/ .
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
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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