Research Nurse Safety Reporting Specialist
- Employer
- Johns Hopkins University
- Location
- Maryland, United States
- Salary
- Salary Not Specified
- Date posted
- Sep 15, 2021
View more
- Position Type
- Administrative, Academic Affairs, Research Administration
- Employment Type
- Full Time
The Transplant Oncology and Infectious Diseases Clinical Research Center (TOID CRC) is looking for an experienced Research Nurse Safety Reporting Specialist to be a part of the clinical research safety reporting team. Our research focuses on solid organ transplantation and in particular novel transplantation practices such as organ donation from donors with HIV and hepatitis C. We are also studying COVID -19 in the transplant recipient population. The TOID CRC is responsible for the oversight and management of numerous multi-centered national and international clinical trials.
Specific Duties & Responsibilities:
Case and Event Review and Reporting
-
Reviews clinical
narratives related to Adverse Events (AEs) and Serious Adverse
Events (SAEs) reported to the TOID Clinical Research
Center.
Help develop common
clinical queries for AEs and SAEs according to each protocol’s
severity grading and relationship to study
intervention.
Initiate data
clarification queries to partner clinical sites about reported
adverse events and track each to resolution.
Ability to apply knowledge
of pathophysiology and pharmacology to assist in the development of
case report forms.
Code AEs and SAEs
according to a standard coding system and upload reports through
each reporting system as defined in protocol’s safety management
plan.
Collaborate with TOID
Research staff members to develop comprehensive safety management
plan for each new protocol.
Assist with the
preparation of routine and ad hoc safety reports for review by
internal and external safety monitoring boards.
Demonstrate knowledge of
safety concepts, per FDA guideline for IND safety
reporting
Prepare IND reports for
submission to the FDA.
Assist in the development
of standard operating procedures and regulatory policy for the
Center.
-
Bachelor’s Degree in
Nursing or related science.
Requires a minimum of two
years related research experience.
Must have clinical trials
experience.
-
Minimum of two years’
experience in nursing preferred.
- Hospital clinical research; transplant/oncology patients, REDCap experience, experience with MedDRA coding is preferred.
-
Individual must be a
registered nurse, licensed in the State of Maryland or state where
practicing.
Must maintain current
licensure and certification during duration of
employment.
Acceptable completion of
the JHH or BMC credentialing process is required within two weeks
of start date.
- Exceptional written and verbal communication skills.
- Ability to work as part of a team, proficiency in Microsoft Office Suite, meticulous record keeping.
Additional Requirements:
- Required work schedule 5 days per week plus on-call weekends approximately 1-2 weekend a month plus rotating holiday.
- On-call is remote.
Classified Title: Research
Nurse
Working Title: Research Nurse Safety Reporting Specialist
Role/Level/Range: ACRP/03/ME
Starting Salary Range: $61,550 - $84,700 annually (commensurate
with experience)
Employee group: Full Time
Schedule: Mon-Friday 8:30am-5pm
Exempt Status: Exempt
Location: School of Medicine Campus
Department name:
SOM DOM Infectious Disease
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 jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.
Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons or because the individual is pregnant or attempting to become pregnant. Requests for an exception must be submitted to the JHU vaccination registry. 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 on which campus you will work. 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.
EEO is the
Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf
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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