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. We are seeking a Research Assistant who 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 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
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 (Mandatory):
Bachelor's Degree in related field with 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: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for the 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.
** Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
IRB knowledge a plus
Basic knowledge of FDA, ICH and other regulatory guidelines related to IRB oversight
JHM IRB policy guidelines and systems
Strong IT skills and ability to learn new software program
Special Knowledge, Skills & 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 Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.26 - $22.35/hr (commensurate with experience) Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Non-Exempt Location: School of Medicine Campus Department name: SOM Neuro BIOS 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 campus. 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.
Equal Opportunity Employer Note: Job Postings are updated daily and remain online until filled.
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.