Research Nurse Safety Reporting Specialist
- Full-Time
- Baltimore, MD
- Johns Hopkins University
- Posted 3 years ago – Accepting applications
Job Description
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.
Minimum Qualifications (Mandatory):
Bachelor's Degree in Nursing or related science.
Requires a minimum of two years related research experience.
Must have clinical trials experience.
Preferred Qualifications:
Minimum of two years' experience in nursing preferred.
Hospital clinical research; transplant/oncology patients, REDCap experience, experience with MedDRA coding is preferred.
Licensure, Certification, Registration:
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.
Special Knowledge, Skills & Abilities:
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
Apply to this Job
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.
Minimum Qualifications (Mandatory):
Bachelor's Degree in Nursing or related science.
Requires a minimum of two years related research experience.
Must have clinical trials experience.
Preferred Qualifications:
Minimum of two years' experience in nursing preferred.
Hospital clinical research; transplant/oncology patients, REDCap experience, experience with MedDRA coding is preferred.
Licensure, Certification, Registration:
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.
Special Knowledge, Skills & Abilities:
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