The Research Assistant will produce and maintain Regulatory Binders for multiple studies with all required documents and additional sections for future documents. The Regulatory Specialist will work closely with the research study staff to ensure all documents are submitted to the IRB and study sponsor in a timely manner.
Work closely with the Primary Investigator, Nurse Manager and Research Nurses on new study applications to ensure timely, accurate and complete submission to the IRB, ICTR and sponsors.
Obtain and assemble all required regulatory documents for new submissions to the IRB.
Prior to the start of a study, this position will ensure all proper regulatory documents have been submitted to and approved by the sponsor and that all documents, CRFs, databases, monitoring/auditing requirements have been completed by Clinical, Lab, Pharmacy, and Nutrition staff.
Work closely with all sponsors to ensure all documents are reviewed, approved and correct prior to a study initiation.
Track each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process.
Produce and maintain a Regulatory binder prior to study starting with all required documents.
Attend study start up meeting for studies.
Work closely with the Primary Investigator, Nurse Manager and Research Nurses to ensure smooth implementation of new trials from conception through study activation.
Prepare reports and present updates to the research team on protocol submission process.
Assist study team in collecting all required documents from outside sites where Johns Hopkins is the coordinating center prior to study initiation.
Work closely with the research study team to ensure all documents are being collected in a timely manner and all regulatory binders are up-to-date.
Assist Nurse Manager in developing regulatory-related Standard Operating Procedures.
Assist research team in the auditing and monitoring of studies.
Bachelor's degree in related discipline. 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 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.
Classified Title: Research Assistant Working Title: Research Assistant Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.10 - $22.12 (commensurate with experience) Employee group: Full Time Schedule: Mon-Friday, 8:30 am - 5:00 pm Exempt Status: Non-Exempt Location: 04-MD:School of Medicine Campus Department name: 10003081-SOM Ped Immunology Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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.
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