Research Assistant, sIRB

The Department of Neurology is seeking a Research Assistant, sIRB to support the BIOS Clinical Trials Coordinating Center (CTCC), which manages multi-center, 30+ million dollar federally funded clinical trials and multiple site-specific pharmaceutical sponsored trials. BIOS CTCC, is also an NIH (National Institutes of Health) funded JHU Trials Innovation Center (TIC), incorporates the TIC, as part of the NIH Trial Innovation Network (TIN) initiative to address roadblocks in clinical trials and accelerating the translation of novel interventions into life-saving therapies. The sIRB Research Assistant will 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. They will also provide support to the Division faculty, administrator, and research personnel.

The Research Assistant, sIRB will report to the IRB navigators and program managers for large multisite clinical trials in managing central IRB documents and agreements in online systems, creating reports, and distributing documents;

Specific Duties & Responsibilities

• Track agreement execution status, uploads documents to online repositories, records activity dates, and reports status summaries.

• Develop and maintain records of research activities, and prepares regular and ad hoc reports, as required.

• Assist in the maintenance of project databases.

• Assist in the development of tables and figures for reports and presentations.

• Assist in the coordination and participates in research team meetings which will include: scheduling meetings, creating agendas and meeting minute transcription.

• Assist in preparing IRB protocols and related documents.

• Communicate with study sites to request documents and answer inquiries.

• Perform miscellaneous job-related duties as assigned.

• Identify and report site issues to managers.

Special Knowledge, Skills & Abilities

• Must have strong organizational skills, attention to detail, be able to work independently and an ability to work with a team of researcher managers.

• Strong IT skills and ability to learn new software program.

• Ability to follow multiple, detailed directions of various protocols.

• Must have excellent time management skills.

Minimum Qualifications

• Bachelor's Degree in related field with some related experience.

• Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula

Preferred Qualifications

• IRB knowledge preferred.

• Knowledge of medical terminology highly desired.

• Basic knowledge of FDA, ICH and other regulatory guidelines related to IRB oversight.

• Experience with JHM IRB policy guidelines and systems.

Classified Title: Research Assistant

Job Posting Title (Working Title): Research Assistant, sIRB

Role/Level/Range: ACRO40/E/03/CD

Starting Salary Range: $17.00 - $30.00 HRLY ($48,880 budgeted; commensurate with experience)

Employee group: Full Time

Schedule: Monday - Friday 8:30 am - 5:00 pm

Exempt Status: Non-Exempt

Location: Hybrid/School of Medicine Campus

Department name: SOM Neuro BIOS

Personnel area: School of Medicine

Equal Opportunity Employer

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.