Research Assistant, sIRB

Location
Maryland, United States
Salary
Salary Not Specified
Posted
Feb 16, 2021
Employment Type
Full Time

General Summary/Purpose:

Support the Brain Injury Outcomes Services (BIOS) Research Program and Clinical Trials Unit, which manages multi-center, 20+ million dollar federally funded clinical trials and multiple site-specific pharmaceutical sponsored trials. Provide support to the Division leadership.

The Johns Hopkins Tufts Trial Innovation Center (TIC) is funded by a seven year NCATS award with the aim of improving operational innovation in large multicenter clinical research studies. The Research Assistant will be responsible to provide support for research projects managed by the JHM IRB serving as the central IRB of record for TIC and non-Tic projects. The Research Program Assistant is responsible for communications, data collection, entry, analysis, and reporting and document management functions.

Specific Duties/Responsibilities:

  • Reports to the cIRB navigators and program managers for large multisite clinical trials in managing central IRB documents and agreements in online systems, creating reports, and distributing documents;
  • Tracks agreement execution status, uploads documents to online repositories, records activity dates, and reports status summaries;
  • Develops and maintains records of research activities, and prepares regular and ad hoc reports, as required;
  • Assists in the maintenance of project databases;
  • Assists in the development of tables and figures for reports and presentations;
  • Assists in the coordination and participates in research team meetings; schedules meetings; create agendas; complete minutes;
  • Assists in preparing IRB protocols and related documents;
  • Communicate with study sites to request documents and answer inquiries
  • Performs miscellaneous job-related duties as assigned.
  • Identifies reports site issues to managers
Minimum Qualifications:

  • Bachelor’s degree in a related field required.
  • Some related experiencerequired.
  • 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.

Preferred Qualifications:

  • Strong IT skills and ability to learn new software program.
  • IRB knowledge a plus.
  • Basic knowledge of FDA, ICH and other regulatory guidelines related to IRB oversight.
  • JHM IRB policy guidelines and systems.

Special Knowledge, Skills, and Abilities:

  • Must be able to prioritize and coordinate multiple tasks, with the ability to prioritize and organize communications and reports, meet deadlines, and understand and appreciate the tasks and processes required. Must have the ability to work well and communicate effectively with others both orally and in writing. Must have strong organizational skills, attention to detail, be able to work independently and an ability to work with a team of researcher managers.
  • Working knowledge of PC operations and software applications such as MS Windows, Excel, Word, and Access required. Ability to learn new database and software applications is required. Ability to follow multiple, detailed directions of various protocols. Knowledge of medical terminology highly desired. Must have excellent time management skills.
Classified title: Research Assistant

Working title: Research Assistant

Role/Level/Range: ACRO 37.5/E/03/CD

Starting Salary Range: $16.26 - $22.35 (commensurate with experience)

Employee group: Fulltime

Employee Status: Non-Exempt

Schedule: Monday-Friday –8:30am-5:00pm 37.5hrs/Wk

Location: 750 E Pratt St., Baltimore, MD

Department name:10003520-SOM Neurology BIOS

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 atjhurecruitment@jhu.edu. 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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf

School of Medicine - East Baltimore Campus


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 jhurecruitment@jhu.edu. 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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

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