Requisition ID:  116118

Research Assistant, Safety

The Department of Neurology is seeking a Research Assistant, Safety that will support the BIOS Clinical Trial Coordinating Center (CTCC), which manages multi-center, 20+ million dollar federally funded clinical trials and multiple site-specific pharmaceutical sponsored trials. 


Specific Duties & Responsibilities


Safety and Risk Assessment, Surveillance, and Management

  • Monitor, document, and resolve safety events for multiple multi-center studies
  • Update data and safety monitoring plans in accordance with study modifications
  • Develop and document internal safety monitoring processes
  • Develop and coordinate clinical event committee tasks, meetings, and regulatory documentation
  • Organize and facilitate multi-disciplinary Risk Assessment meetings / Risk Management meetings
  • Facilitate Safety Monitoring Plan draft development and version management per funded project
  • Facilitate QA Monitoring Plan draft development and version management per funded project
  • FDA file management as needed for projects managed by BIOS CTCC
  • Manage BIOS CTCC SOP/WI/Form library and training documentation for all Operational plans, FDA submission documents, workflow supporting materials (email templates, CAPA plans, etc.),
  • Data management of RACT REDCap, QA effort tracking and various EDC system navigation, Safety Event workflow tracking and various EDC system navigation, FDA system use and submission tracking, financial management to pay MM contractors
  • Report to weekly team meeting (per team), weekly trial operations meetings (per trial supported), BIOS Monthly Ops (monthly), manuscript preparation (ad hoc)


Research Support

  • Assist with annual reports, IRB applications, and FDA reporting.
  • Handle source documents, literature searches, write summaries, assist with writing grants and standard operational procedures, and prepare journal manuscripts.
  • Provide analytical support to data analysts and research support as required to include PowerPoint presentations and general correspondence.
  • Participate in project related meetings and develop-implement needed quality control procedures and tasks. Organize materials and maintain filing systems.
  • Provide telephone and correspondence management.
  • Perform data entry and data editing.
  • Assist with basic data management tasks such as running queries on existing databases, organizing, and editing data, conducting reliability checks.
  • Comply with all regulatory and institutional requirements related to clinical research.
  • Combine, distribute, and ship documents.
  • Perform other duties as required.


Minimum Qualifications
  • Bachelor's Degree in related discipline.
  • Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.

 


 

Classified Title: Research Assistant 
Job Posting Title (Working Title): Research Assistant, Safety   
Role/Level/Range: ACRO40/E/03/CD  
Starting Salary Range: $17.20 - $30.30 HRLY (Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F 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 

 

 


Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/.

Education and Experience Equivalency
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: 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 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 Completing Studies
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.

Background Checks
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information
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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/.

Vaccine Requirements
Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. 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 upon 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.

Hybrid: On-site 1-2 days a week